MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HAND CHUCK FOR K-WIRES; GUIDE

Model Number	392.040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.The device has been 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 an unknown date, during incoming inspection of a loaner set, it was observed that the hand chuck for k-wires was damaged with a broken tip.There was no patient involvement.This report involves one (1) hand chuck for k-wires.This is report 1 of 1 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: 392.040 (32961).Lot: 2255598.Manufacturing site: bettlach.Release to warehouse date: march 16, 2007.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the hand chuck for k-wires was received at us customer quality (cq) for investigation.Visual inspection of the received device indicated that one of the chuck jaws in flutter component was broken off.Thus, the complaint condition was confirmed for the received device.A concomitant unknown k-wire piece was also received at us cq.No other issues were identified on the device.Dimensional inspection: the dimensional inspection cannot be performed due to post-manufacturing damage.Document/specification review: the following drawings were reviewed: manual chuck (manufactured drawing).Manual chuck (current drawing).Flutter (manufactured drawing & current drawing).Conclusion: the overall complaint was confirmed for the received device as a component in the device was broken.No definitive root cause could be determined based on the provided information.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: HAND CHUCK FOR K-WIRES
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10017923
• Report Number: 2939274-2020-02173
• Device Sequence Number: 2436918
• Product Code: FZX
• UDI-Device Identifier: 10886982198617
• UDI-Public: (01)10886982198617
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 04/17/2020

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 Model Number: 392.040
• Device Catalogue Number: 392.040
• Device Lot Number: 2255598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Initial Date Received by Manufacturer: 04/17/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1