MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 135 DEG DHS® PLATE-STANDARD BARREL 3 HOLES/62MM; APPLIANCE,FIXATION,NAIL

Model Number	281.131
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient weight is not provided for reporting.Additional product code: jdo.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 an initial surgery for implantation of a dynamic hip system (dhs) into the proximal femur was performed on (b)(6) 2018.During the surgery, the lag screw for the dhs plate was put in correctly, however, the plate was put in off-axis.Therefore, the plate had to be re-positioned, and as the surgeon was removing the connecting screw and guide shaft from the lag screw, the two instruments became bent (it was reported that the surgeon did not disconnect the instruments prior to taking them out) and the surgeon had to use pliers to take the instruments out.The same plate was put back into the patient without issue.A guide wire was also reported to be bent during the surgery.The patient was implanted with a lag screw, plate and three 4.5 mm cortical screws (size 36, 42 and 48 mm).There was no reported delay and the surgery was completed successfully.It was further reported that in sterile processing the connecting screw broke into two (2) pieces and the guide shaft, still in one piece, was bent trying to get them apart.This complaint is linked with (b)(4) for the post-operative event of broken/bent (connecting screw and guide shaft) instruments.Concomitant devices reported: dhs/dcs lag screw 12.7 mm thread/90 mm (part # 280.900, lot # unknown, quantity # 1), 4.5 mm cortex screw (part # unknown, lot # unknown, quantity # 3) this complaint involves three (3) devices.This report is 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.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
This is report 4 of 4 for (b)(4).

• Brand Name: 135 DEG DHS® PLATE-STANDARD BARREL 3 HOLES/62MM
• 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: 7351462
• Report Number: 2939274-2018-51108
• Device Sequence Number: 18841986
• Product Code: KTT
• UDI-Device Identifier: 10886982176660
• UDI-Public: (01)10886982176660(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K791619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2018

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: 281.131
• Device Catalogue Number: 281.131
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR