MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS®/DCS® COUPLING SCREW; MISC ORTHO SURGICAL INSTR

Model Number	338.20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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, the patient underwent an unknown procedure.During the procedure, a dynamic hip and condylar screw (dhs/dcs) coupling screw would not thread onto the lag screw.It was discovered to have broken threads.A new connecting screw was selected from the set and was used but it would not thread onto the dynamic hip and condylar screw (dhs/dcs) lag screw.It was discovered that the dhs/dcs lag screw had an internal blemish preventing the threading.A second dhs implant set was opened for a new dhs/dcs lag screw.The procedure was successfully completed with a five (5) minutes surgical delay.There was no patient consequence.Concomitant devices reported: unk - insertion instruments: connecting / coupling screw: trauma (part # / lot # / quantity: unknown).This complaint involves two (2) devices.This report is for one (1) dhs®/dcs® coupling screw.This is report 2 of 2 for (b)(4).
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.Investigation summary visual inspection: the dhs®/dcs® coupling screw (p/n 338.20 lot 6076782) was received showing a portion of the distal threads broken off and embedded in the returned mating dhs®/dcs® lag screw 12.7mm thread/105mm (p/n 280.050 lot 7478343 under ip-00676192 pi-15675154669680809).Dimensional inspection: dimensional inspection of dhs/dcs coupling screw threads was not conducted as the remaining thread form on the coupling screw does not provide an accurate measurement for any thread diameters.Document/specification review: drawings, reflecting the manufactured and current revision, was reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the dhs®/dcs® coupling screw (p/n 338.20 lot 6076782) as a portion of the distal threads was broken off and embedded in the returned mating dhs®/dcs® lag screw 12.7mm thread/105mm (p/n 280.050 lot 7478343).While no definitive root cause could be determined for the broken coupling screw, it is possible that the two parts were cross-threaded, unintended/excessive forces caused the coupling screw to break, and the portion of the broken thread fragment of the coupling screw remained in the lag screw.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.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.Device history lot part number: 338.20 synthes lot number: 6076782 supplier lot number: n/a release to warehouse date: 23mar2009.Expiration date: n/a.Manufactured by synthese brandywine.No ncrs were generated during production.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: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9100891
• Report Number: 2939274-2019-60757
• Device Sequence Number: 14117631
• Product Code: LXH
• UDI-Device Identifier: 10886982193223
• UDI-Public: (01)10886982193223
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Report Date (Section B): 08/23/2019

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: 338.20
• Device Catalogue Number: 338.20
• Device Lot Number: 6076782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 10/18/2019
• 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 - CONNECTING SCREW: TRAUMA; UNK - CONNECTING SCREW: TRAUMA
• Patient Age: 76 YR