MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS/DCS COUPLING SCREW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	338.20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 (b)(6) 2020, during the application of a dynamic hip system (dhs) for an intertrochanteric fracture the dhs coupling screw broke along with the two (2) tip for dhs impactor.It was unknown if there were fragments generated.Another set was opened, and the items were pulled from the second set.It was unknown if there was a surgical delay.The procedure was successfully completed.The patient outcome was unknown.Concomitant devices reported: tip for dhs®/dcs® impactor (part number 338.26, lot 6043333, quantity 1), tip for dhs®/dcs® impactor (part number 338.26, lot h479753, quantity 1).This report involves one (1) dhs®/dcs® coupling screw.This is report 3 of 3 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.H3, h4, h6 investigation summary.Visual inspection: the dhs®/dcs® coupling screw (p/n: 338.20, lot number: h479753) was received at us cq.Visual inspection of the complaint device showed the distal threaded tip was broken off.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection could be performed due to post-manufacturing damage.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 distal threaded tip is 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.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: part: 338.200.Lot: 1165694.Manufacturing site: hägendorf.Release to warehouse date: 07 march 2003.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: DHS/DCS COUPLING SCREW
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10560263
• Report Number: 2939274-2020-04222
• Device Sequence Number: 16792005
• Product Code: LXH
• UDI-Device Identifier: 10886982193223
• UDI-Public: (01)10886982193223
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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: 338.20
• Device Catalogue Number: 338.20
• Device Lot Number: 1165694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 10/13/2020
• 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: TIP FOR DHS®/DCS® IMPACTOR (338.28); TIP FOR DHS®/DCS® IMPACTOR (338.28); TIP FOR DHS®/DCS® IMPACTOR (338.28); TIP FOR DHS®/DCS® IMPACTOR (338.28)
• Patient Weight: 91