MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BALL HEX SCREWDRIVER 8MM FOR TI FEMORAL NAILS; SCREWDRIVERS

Model Number	357.515
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
It was reported that on (b)(6) 2019, during trochanteric nail procedure, the insertion handle & cannulated connecting screw would not disengage from the nail.Allegations of devices insertion handle and connecting screw would not disengage from nail.Broke wrench and two (357.397 and one 521.30) ball hex screwdrivers trying to remove insertion handle from nail.Fragments were generated from broken devices.Surgeon ended up removing the entire construct and redid the operation with a different set and new nail.Other medical intervention was to remove implanted product and start procedure over with new sets and implants.Procedure ended up being done successfully with new system and nail surgery was delayed by 45 minutes with no less desirable outcome.Concomitant device reported: unk - nails (part # unknown, lot # unknown, quantity # 1).This is report 4 for 4 (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.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 synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: investigation summary complaint summary: 9/6/2019: updated event description: it was reported that on (b)(6) 2019, during trochanteric nail procedure, the insertion handle & cannulated connecting screw would not disengage from the nail.Broke wrench and two (2) ball hex screwdrivers trying to remove insertion handle from nail.Fragments were generated from broken devices.Surgeon ended up removing the entire construct and redid the operation with a different set and new nail.Procedure ended up being done successfully with new system and nail surgery was delayed by 45 minutes with no less desirable outcome.Concomitant device reported: unk - nails (part # unknown, lot # unknown, quantity # 1) this complaint involves five (5) devices.Flow: damage visual inspection: the ball hex screwdriver 8 mm for ti femoral nails was received at us cq with broken handle into two pieces and the dowel pin was missing.Hence, the complaint is confirmed.Dimensional inspection: dimensional analysis was not performed as relevant features are significantly deformed.Document/specification review: the following drawing(s) was reviewed; ball hex screwdriver, 8 mm for ti femoral nails: 357_515 rev b and rev e conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.As per provided information, the ball hex screwdrivers broke while removing insertion handle from nail.It is most likely due to the application of unintended forces.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H3, h4, h6: a review of the device history record.Device history lot part # 357.515 synthese lot # 4568012 supplier lot # na release to warehouse date: 08 may 2003, manufactured by synthese brandywine.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.No ncr's were generated during production device history batch null, device history review =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.
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.H6: code 3191 used to capture device failure.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: BALL HEX SCREWDRIVER 8MM FOR TI FEMORAL NAILS
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9106808
• Report Number: 2939274-2019-60810
• Device Sequence Number: 16672372
• Product Code: HXX
• UDI-Device Identifier: 10886982196514
• UDI-Public: (01)10886982196514
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/27/2019

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: 357.515
• Device Catalogue Number: 357.515
• Device Lot Number: 4586012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 09/30/2019; 10/10/2019; 04/07/2020
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 09/30/2019; 10/22/2019; 04/08/2020
• 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: UNK - NAILS; UNK - NAILS
• Patient Age: 86 YR
• Patient Weight: 64