MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-05-03 for LORENZ NEEDLEHOLDER DEL MICRO TC N/A 51-6598 manufactured by Biomet Microfixation.
[74293069]
The user facility is foreign; therefore a facility medwatch report will not be available. Without a product return, no product evaluation is able to be conducted. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[74293070]
It is reported the needle holder broke during a "flap" procedure that took place on (b)(6) 2017. The device is said to have been inspected by the customer prior to clinical/ patient use. A part of the jaw of the needle holder fell into the patient and it was removed. There was no delay that exceeded thirty minutes. The procedure was completed using another needle holder. There was no injury to the patient and the patient is in stable condition.
Patient Sequence No: 1, Text Type: D, B5
[83319702]
The device evaluation is in progress, a follow up report will be sent upon completion of the device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[83319908]
The product identity was confirmed in the product evaluation. Visual evaluation confirms that the needle holders are broken. One of the jaws has completely fractured off and was not returned with the product. The most likely cause of the complaint is determined to be excessive force on the needle holders when squeezing to grip a needle. Aesthetically, the instrument looks to be in good condition with minimal signs of wear. Instructions for use states: avoid undue stress or strain when handling or cleaning instruments. The non-conformance database was reviewed and there are no non-conformances.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001032347-2017-00337 |
| MDR Report Key | 6540439 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-03 |
| Date of Report | 2017-05-03 |
| Date of Event | 2017-01-15 |
| Date Mfgr Received | 2017-07-27 |
| Device Manufacturer Date | 1997-04-23 |
| Date Added to Maude | 2017-05-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MICHELLE COLE |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LORENZ NEEDLEHOLDER DEL MICRO TC |
| Generic Name | HOLDER, NEEDLE; ORTHOPEDIC |
| Product Code | HXK |
| Date Received | 2017-05-03 |
| Returned To Mfg | 2017-06-30 |
| Model Number | N/A |
| Catalog Number | 51-6598 |
| Lot Number | 428420 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-03 |