MAUDE Adverse Event Report: SYNTHES GMBH BUTTRESS/COMPRESSION NUT FOR 357.369; APPARATUS, TRACTION, NON-POWERED

Catalog Number 357.371

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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 (b)(6) reports an event as follows: it was reported that patient underwent a proximal femur osteosynthesis procedure on (b)(6) 2021, using the trochanteric femoral nail (tfn) system.At the time of the placement of the guide sheath for the spiral blade, it was not possible to fully face (finish); this happened because ¿the material that helps for this guide to fit correctly, when it reached the next third of said guide, it did not continue screwing,¿ (it remained stuck) and a maximum lever effort had to be made so that it could be brought closer.But it came to a point where the surgical team could no longer screw; leaving this guide separated from the cortex and giving a not so exact measurement of the spiral blade to be placed.The surgeon made an estimate on this measurement, since there was no other instrument that could replace this guide at that moment.The spiral sheet to be placed was chosen, and it was inserted leaving a suitable length.The procedure terminated with no greater impact to the patient.This report is for a buttress/compression nut.This is report 2 of 2 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Visual inspection: the buttress/compr-nut f/357.369 (part #: 357.371, lot #: h350057) was returned and received at us cq.Upon visual inspection, no issues were identified.Functional test: the device was received assembled with the guide sleeve f/helical blade f/tfn.However, the devices were able to be assembled and disassembled without any issue.Document/specification review the current and manufactured revision of drawings were reviewed: buttress/compression nut for blade guide sleeve, tfn: 357_371, rev.E/d dimensional inspection: no dimensional inspection was performed as the devices were able to function as intended.Investigation conclusion the complaint condition could not be confirmed for the returned device.There is no indication that a design or manufacturing issue has caused the issue.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot - part # 357.371 synthes lot # h350057 supplier lot # h350057 release to warehouse date: 10 nov 2017 supplier: isimac machine company no ncr's were generated during production.Device history review
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> review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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: BUTTRESS/COMPRESSION NUT FOR 357.369
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SALZBURG; vorgartenstrasse 206b; wien 1020 ; AU 1020
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12760605
• MDR Text Key: 284872476
• Report Number: 8030965-2021-09339
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 07611819737570
• UDI-Public: (01)07611819737570
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 357.371
• Device Lot Number: H350057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BLD GUIDE SLEEVE FOR TFN