MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC THREADED HAMMER GUIDE CONNECTOR; MISC ORTHO SURGICAL INSTR

Model Number	03.037.120
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2020
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 a synthes employee.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
It was reported that on (b)(6) 2020, during hip surgery, the driving cap did not thread into the fitting properly.Even though, the driving cap was not threaded all the way in, the surgeon malleted the driving cap.There was a surgical delay of five (5) minutes.The procedure was successfully completed.There was no patient consequence.Concomitant devices reported: mallet (part number unknown, lot unknown, quantity 1), insertion handle (part number unknown, lot unknown, quantity 1).This report involves threaded hammer guide connector.This is report 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: part #: 03.037.120.Synthes lot number: 9804223.Manufacturing site: unk.Release to warehouse date: unk.Per jde, the device was received/created on may 7, 2015.A manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure 100673626 no manufacturing record evaluation is required.No combination could be found in synthes systems for part 03.037.120/lot 9804223.Therefore a dhr review could not be performed at this time.If further information becomes available for this part, then this dhr review will be revisited.Visual inspection: the threaded hammer guide connector (p/n: 03.037.120, lot number: 9804223) was received at us customer quality (cq).Visual inspection of the complaint device showed the internal threads were stripped, leading to the complaint condition.However, the device is unable to assemble instead of unable to disassemble.This is reflected in the event description.Functional test: a functional assessment was performed with the complaint device and the returned mating device.The complaint device was unable to properly thread onto the mating device.The condition can be replicated dimensional inspection: a dimensional inspection was not performed due to post manufacturing damage and device geometry.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes investigation conclusion: this complaint is confirmed as the internal threads are stripped, causing the complaint condition.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 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: THREADED HAMMER GUIDE CONNECTOR
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9866422
• Report Number: 2939274-2020-01464
• Device Sequence Number: 14213185
• Product Code: LXH
• UDI-Device Identifier: 10886982070586
• UDI-Public: (01)10886982070586
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.037.120
• Device Catalogue Number: 03.037.120
• Device Lot Number: 9804223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/16/2020
• 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 - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - NAIL INSERTION HANDLES
• Patient Age: 81 YR
• Patient Weight: 102