MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS®/DCS® COMPRESSION SCREW 36MM; APPLIANCE,FIXATION,NAIL

Model Number	280.990
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant and explant dates: implant and explant date not applicable.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 while attempting to implant the dhs/dcs compression screw during a case on (b)(6) 2018 the last few turns became very difficult.On the last turn the set screw (head of the dhs/dcs screw) snapped off and was discarded.The remainder of the compression screw remains implanted.Proper compression was achieved, and the product performed as expected.No surgeon follow up required.There was no surgical delay, and the patient's outcome was reportedly good.There is one device involved in this complaint.This is report 1 of 1 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.Device was used for treatment, not diagnosis.Device is a single use device but was not reprocessed or reused.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® COMPRESSION SCREW 36MM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7396855
• Report Number: 2939274-2018-51440
• Device Sequence Number: 10932711
• Product Code: KTT
• UDI-Device Identifier: 10886982176356
• UDI-Public: (01)10886982176356(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K791619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2018

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: 280.990
• Device Catalogue Number: 280.990
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2018
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1