MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA Ø10 SM 130° L200 TAN; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 472.375S

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) (french territory) as follows: the distributor reports that during the opening of the product, the surgeon discovered that through the plastic film there was a hair inside the implant sterile packaging.This complaint involves one (1) device.This is 1 of 1 for report (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Part: 472.375s.Lot: 5l03605, manufacturing site: (b)(4).Release to warehouse date: (b)(6) 2019.Expiry date: 01.July 2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Result of material evaluation: we analysed the product and found out that the hair is not in the sterile barrier but in the packaging.We sensitised the employees to hygiene in the workplace.After internal clarifications, we inform you that the report will not change.Result of picture review: früh verpackungstechnik ag confirms the reason for the complaint.The pictures show that there is a hair inside the bag.However, based on the picture provided it can¿t be said in which peel pouch it is contained.Process overview: the medicinal product is packed into the peel pouches in an iso 7 clean room environment.The operators are dressed according to the personal hygiene behavior of employees specified in sop, including a hair net and additional beard protection for men.During the entire process step, the employees always wear a hair net, cleanroom clothing including gloves and, for the men, an additional beard protection net.The production papers for production order 01632214 were checked and no deviation could be detected.The products including the packaging materials are checked after packaging according to sop.Root cause: although the employees are well trained and wear a hair net and men wear a beard protection net, a single hair cannot be excluded, even if the room is classified as iso-7.The company früh confirms the finding.However, as such a deviation can never totally be excluded and hygiene measures are in place, further actions are not taken.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFNA Ø10 SM 130° L200 TAN
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9330126
• MDR Text Key: 191131969
• Report Number: 8030965-2019-70316
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819289277
• UDI-Public: (01)07611819289277
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 472.375S
• Device Lot Number: 5L03605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Date Manufacturer Received: 12/03/2019
• Patient Sequence Number: 1