MAUDE Adverse Event Report: SYNTHES 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event occurred on an unknown date in 2020.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 on (b)(6) 2020 that the thread of the insertion handle was damaged and unable to connect to the aiming arm.This was discovered during the sterilization procedure.There was no patient or surgical impact.This report is for one (1) radiolucent insertion handle f/trochanteric fixation nails.This is report 1 of 2 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.H6: picture review: the review of the provided picture does not allow to verify the complaint condition as the inner thread of the insertion handle is not visible on the picture.H3, h6: a product investigation was conducted.Visual inspection: the visual inspection confirmed that the first thread flanks in the hole, in which the connector will be assembled are slightly damaged.This damage prevents the proper functioning.Besides, the instrument is in good condition.There are no further discernible signs of damage.Dimensional inspection: the relevant dimensions cannot be verified due to the damage incurred.Document/specification review: relevant drawing and the information leaflet ¿end of life indicators (eoli) of reusable instruments functional control document¿ were reviewed during this investigation.The present thread damage is covered in section 2.6 ¿instruments with interlocking threads¿.Summary: the complaint condition is confirmed as the thread in the hole, in which the connector will be assembled, is slightly damaged.This production lot (9939837 ) was manufactured in june 2016 according to the specification.The parts conformed to the specifications at the time of manufacturing and passed inspection requirements with no non-conformities noted.We only have limited information about the origin of this damage as it was discovered during the cleaning procedure.However, it is most likely that any unintended excessive forces during use with the connector have contributed to the complaint condition.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Please find further information for end of life indicators of reusable instruments in se_737926 revision aa.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.A device history record (dhr) review was conducted: part number: 03.010.405, lot number: l160089, manufacturing site: haegendorf, release to warehouse date: 30 june 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10942279
• Report Number: 8030965-2020-09364
• Device Sequence Number: 584087
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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: 9939837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONNEC F/INSERTION HANDLE F/PFNA; CONNEC F/INSERTION HANDLE F/PFNA