MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06,07 report with the FDA on 2011-03-24 for POWERPRO STERILE TRANSFER CASE, LARGE PRO3110 manufactured by Conmed Linvatec.
[1893309]
The customer reported that toward completion of a total hip surgery, the surgeon observed a crack in the sterile transfer battery case in use, and through this crack in the area of the weld, the unsterile battery could be seen. The customer reported that as the surgery was completed and the patient had already been given prophylactic antibiotics for the procedure, the surgeon did not pursue further intervention. No patient injury or adverse outcome was reported. Subsequent review of this complaint found that the sterile barrier may have been compromised.
Patient Sequence No: 1, Text Type: D, B5
[9080464]
Investigation results: an evaluation was unable to be performed as the user facility chose to retain the device. Upon examination of the photos that were provides by the customer, it was determined that the battery case was not cracked as initially stated. The battery case appears to be separating at the weld seam. A review of the device history record indicates that pro3110 lot # 108945 is a lot of 60 pieces that was completed on (b)(4) 2009. There was nothing noted on the dhr that would correlate to the separation of the transfer cases at the weld seam. A stock audit did not find any additional pro3110 devices with the weld seam failure. Invest-344 was opened to investigate this issue. The most probable cause of the failure was determined to be operator error-operator did not perform the leak test on the 3 devices that failed. Ptpro3110 was revised to require the operator to record the actual leak test result for each individual device instead of a single signature that accepts the entire lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2011-00005 |
| MDR Report Key | 2038756 |
| Report Source | 00,05,06,07 |
| Date Received | 2011-03-24 |
| Date of Report | 2011-03-24 |
| Date of Event | 2010-05-19 |
| Date Mfgr Received | 2010-05-19 |
| Device Manufacturer Date | 2009-10-01 |
| Date Added to Maude | 2011-04-27 |
| 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 | 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 | POWERPRO STERILE TRANSFER CASE, LARGE |
| Generic Name | SAW, POWERED, AND ACCESSORIES |
| Product Code | FCO |
| Date Received | 2011-03-24 |
| Catalog Number | PRO3110 |
| Lot Number | OCT09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-24 |