MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 9MM/125 DEG TI CANN TFNA 340MM/LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.925S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: patient identifier, age, date of birth, and weight not available for reporting.Date of device breakage is not known.Complainant part is not expected to be returned for manufacturer review/investigation.Dhr review was completed.Manufacturing location: (b)(4).Manufacturing date: 16-jun-2015.Expiration date: 30-jun-2025.Part #: 04.037.925s (eu item), lot#: 9828183 (sterile) - 9mm/125 deg ti cann tfna 340mm/left- sterile.Quantity (b)(4).Inspection sheet for in process/inspect dimensional/final and inspection sheet for tfna assembly inspection meet specification.Component parts reviewed: 04.037.912.2 - lock prong 125 degree, tfna bp-55 lot ¿ 9345493 , 04.037.912.4 - wave spring, shim ended bp-55 lot - 7840773 , 04.037.912.3 - tfna lock drive bp-58 lot ¿ 7993634 , 21127 - raw material lot bp-80 lot ¿ 9805382.Raw material for ti was received from supplier (b)(4).Certificate of test received from (b)(4) for titanium ingot meet specification.Raw material receiving/putaway checklist meet requirements.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.¿sterility documentation was reviewed and determined to be conforming.¿ the investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported patient was implanted with the 9mm 125 degree cannulated trochanteric fixation nail advanced (tfna) long nail for proximal femoral subtrochanteric fractures on (b)(6) 2016.On unknown date, it was determined that the nail had broken around the bump-cut area of the blade insertion hole.Patient was returned to surgery on (b)(6) 2017 where the nail was exchanged for a tfna long nail.Surgery was completed successfully.Surgeon stated the cause of the nail breakage may have been metal fatigue due to pseudarthrosis.Concomitant device reported: screw (part number unknown, lot number unknown, quantity 1).This report is for one (1) 9mm 125 degree cannulated tfna nail 340mm-left.(b)(4).
Additional Manufacturer Narrative
Physical manufacture site 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: 9MM/125 DEG TI CANN TFNA 340MM/LEFT - STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7469719
• Report Number: 8030965-2018-53422
• Device Sequence Number: 19095725
• Product Code: HSB
• UDI-Device Identifier: 10886982097873
• UDI-Public: (01)10886982097873
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: 04.037.925S
• Device Catalogue Number: 04.037.925S
• Device Lot Number: 9828183
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention