MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS; MISC ORTHO SURGICAL INSTR

Catalog Number	03.010.405
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is synthes sales consultant.A review of the device history records has been requested.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, there was a functional issue with aiming arm, hole for locking bolt at proximal femoral nail antirotation (pfna) could not hit properly.There was no patient harm.There was no surgical delay reported.This report is for one (1) radiolucent insertion handle.This is report 1 of 2 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.A device history record (dhr) review was conducted: part: 03.010.405 lot: l267342 manufacturing site: hägendorf release to warehouse date: 04.April 2017 the device history record shows this lot of 12 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was conducted.Visual inspection: the returned parts aim-arm (03.010.407) and insert-handle (03.010.405) were together assembled.All in all, the parts are shown in used condition.The function test has shown that the proximal hole of femoral nail antirotation (pfna) fit properly as intended.No abnormal findings were identified on these returned parts.Function test: no abnormal findings were identified on these returned parts.The function test has shown that the proximal hole of femoral nail antirotation (pfna) fit properly as intended.Summary: the complaint condition is unconfirmed.The returned parts aim-arm (03.010.407) and insert-handle (03.010.405) were together assembled.All in all, the parts are shown in used condition.The function test has shown that the proximal hole of femoral nail antirotation (pfna) fit properly as intended.No abnormal findings were identified on these returned parts.Based on that and the condition of the parts a product related issue can be excluded.Unfortunately the exact cause which has led to the occurrence could not be evaluated.We only can assume that a mechanical overloading situation, for example strongly torsion (aim-arm against pfna nail) during implantation, or the nail was not tightened enough on the insert handle.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: RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8127001
• Report Number: 8030965-2018-58716
• Device Sequence Number: 2165410
• Product Code: LXH
• UDI-Device Identifier: 07611819349421
• UDI-Public: (01)07611819349421
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2018

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 Catalogue Number: 03.010.405
• Device Lot Number: L267342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 12/18/2018; 01/17/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 01/11/2019; 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1