MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-03-03 for XACTPIN GRAFT PASSING GUIDE PIN, 2.4MM X 43CM C8677 manufactured by Conmed Linvatec.
[14880011]
It was reported that during use of the xactpin graft passing guide pin in an acl reconstruction surgery on (b)(6) 2013, the tip of the pin broke off in the patient? S femoral shaft while reaming/drilling. This was immediately noticed by the surgeon. X-ray was taken and the surgeon believed he would not be able to remove the broken tip from the patient? S femur, the surgeon therefore opted to leave the tip in place. As reported, the surgeon felt the fixation of the acl was achieved and despite the tip breakage, the procedure went well and completed with no further complications or patient injury. The remainder of the guide pin was discarded at the user facility after the surgery. Follow-up with the user facility on (b)(4) 2014 revealed that the patient is recovering well and as expected. At this time, there is no plan for future surgical intervention.
Patient Sequence No: 1, Text Type: D, B5
[15467122]
As reported, the remainder of the guide pin is not expected for evaluation, as it was discarded at the user facility after the surgery. Without the actual product, an evaluation could not be performed and the root cause of the reported breakage was unable to be determined. However, based on received information, which indicated that the tip of the guide pin broke off while reaming/drilling, it is believed that the most probable cause of the pin breakage is due to the reamer attachment inadvertently coming in contact with the guide pin. This device was manufactured on 20-nov-2013. Of the lot containing 25 units, there were no other complaints received. A review of the device history record showed, there were no anomalies or nonconformances noted during the manufacturing process that could have caused or contributed to this reported breakage. Additionally, a two-year review of complaints for this product family showed of (b)(4) units shipped, there was only one (1) similar complaint received. This is a reusable device and the number of usage was not provided. This failure mode is addressed in the device's risk document, and the safety risk has been found to be acceptable. To reduce the risk of guide pin breakage and injury to the patient, the product's instructions for use (ifu) provides the following warnings and precautions: warnings: - neurovascular structures must be avoided when advancing this device. - this device should not be advanced with a mallet. Precautions: - proper knee flexion angles should be confirmed prior to advancement. - leg holder should be placed high on the leg allowing adequate exposure for pin exit. - inspect pin prior to use to ensure it is in good physical condition. Product discarded at the user facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2014-00006 |
| MDR Report Key | 3655843 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-03-03 |
| Date of Report | 2014-02-18 |
| Date of Event | 2013-12-31 |
| Date Mfgr Received | 2014-02-18 |
| Device Manufacturer Date | 2013-11-20 |
| Date Added to Maude | 2014-03-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. BRENDA JOHNSON |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995515 |
| Manufacturer G1 | CONMED LINVATEC |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XACTPIN GRAFT PASSING GUIDE PIN, 2.4MM X 43CM |
| Generic Name | DRIVER, SURGICAL, PIN |
| Product Code | GFC |
| Date Received | 2014-03-03 |
| Catalog Number | C8677 |
| Lot Number | 512950 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | 11311 CONCEPT BLVD. LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-03 |