MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI END CAP FOR TFNA 0MM EXTN - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.000S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is company representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2019, the patient underwent a femoral trochanteric fracture procedure with femoral nailing system (tfna).At the end of the procedure, the surgeon could not insert the tfna titanium end cap.The surgeon used another tfna titanium end cap and inserted it successfully.The surgeon didn¿t apply any extra manipulation, such as adduction, to insert the end cap.The surgery was completed with less than thirty (30) minutes of surgical delay.The patient outcome was stable.Concomitant device reported: trochanteric femoral nailing system (tfna) femoral nail (part# 04.037.913s, lot# unknown, quantity# 1).This is report 1 of 1 for (b)(4).
Additional 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.A device history record (dhr) review was conducted: part: 04.038.000s.Lot: 3l08757.Manufacturing site: bettlach.Release to warehouse date: 12.Feburary 2019.Expiry date: 01.February 2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was conducted.Visual inspection: the received tfna end cap show that the first two thread flanks got damaged.Furthermore, are some deep scratches on the implant visible and the stardrive recess show deep impression marks caused (most probably) by an unknown screwdriver.Dimensional inspection: the outer diameter of the thread close to the damaged area got measured.The measuring result does show conformity.The shaft diameter at the front section got measured and the measuring result does show conformity.Drawing/specification review: the manufacturing document shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.All devices were sold meanwhile, and we are not aware of any quality issues associated with this article- and lot numbers.Failure in material or production could not be detected.Summary: the received condition, that the implant cannot be screwed in to an tfna nail, can be confirmed.However, the condition of the threads, the visible scratches and impression marks at the recess, indicates that complaint was caused by cross-threading and/or forcible use during the insertion.Another reason could be an alignment issue.Finally, we conclude that the cause of failure is not due to any manufacturing non-conformances.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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: TI END CAP FOR TFNA 0MM EXTN - STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8799378
• Report Number: 8030965-2019-66315
• Device Sequence Number: 11472934
• Product Code: HSB
• UDI-Device Identifier: 10886982098344
• UDI-Public: (01)10886982098344
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.038.000S
• Device Catalogue Number: 04.038.000S
• Device Lot Number: 3L08757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 09/11/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA FEM NAIL Ø9 125° L200 TIMO15; TFNA FEM NAIL Ø9 125° L200 TIMO15