MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.3MM PERCUTANEOUS THREADED DRILL GUIDE; GUIDE, SURGICAL, INSTRUMENT

Model Number	324.203
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
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.Without a lot number the device history records review could not be completed.Product was not returned.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) 2021, the surgeon was performing an open reduction internal fixation (orif) of a femur using the distal condylar locking plates and the aiming arm.During the procedure surgeon was having difficulty getting the locking guides to engage with the plate and believed the threads at the tip of the guide were worn.He tried different guides from the set and found one to work easier than others and used that one to finish case.There was surgical delay of two-three (2-3) minutes due to the reported event.The procedure was successfully completed.This report is for one (1) 4.3mm percutaneous threaded drill guide.This is report 1 of 4 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.H3, h4, h6- the 4.3mm percutaneous threaded drill guide (p/n: 324.203, lot #: 3145849) was returned and received at us cq.Upon visual inspection, it was observed that the internal threads were stripped.The observed condition was consistent as an end of life indicator for the device.No other issues were observed with the returned device.Functional test: a functional test cannot be performed as the device was returned by itself.The complaint was confirmed during investigation.After a visual inspection per guidance provide, it is determined that the reusable instrument device is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventative action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot =part: 324.203, lot: 3145849, manufacturing site: hägendorf, release to warehouse date: 25.May 2009.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: 4.3MM PERCUTANEOUS THREADED DRILL GUIDE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11753819
• Report Number: 2939274-2021-02171
• Device Sequence Number: 3091840
• Product Code: FZX
• UDI-Device Identifier: 10886982191205
• UDI-Public: (01)10886982191205
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/06/2021

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: 324.203
• Device Catalogue Number: 324.203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/02/2021
• 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: UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - PLATES; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM.; UNK - PLATES.