MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM; SCREW, FIXATION, BONE

Model Number	202.216
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient¿s height reported as 5 feet 7 inches.Additional device product codes: hrs, ktt.Device broke during insertion; device not considered 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.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 during a distal fibula fracture surgery on (b)(6) 2018, screw head broke off during final tightening.Screw shaft was left in place and retained in the patient bone.There was a surgical delay of 2 minutes due to additional locking screw to compensate for the broken screw.The procedure was successfully completed.Patient outcome is unknown.This report is for one (1) 2.7mm locking screw slf-tpng with t8 stardrive recess 16mm.This is report 1 of 1 for complaint (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.H3, h6: the implant was received with the reported condition of ¿broken (2+ pieces) intraoperatively: rm.¿ the following investigation flow was performed: broken.It was visually observed that the screw shaft (not returned) has sheared off just below the screw head and before the screw threads start (returned).The complaint condition is confirmed and the received condition agrees with the complaint description.The cause of the issue could not be definitively traced to use error, misuse/abuse, non-compliance, postoperative trauma.Dimensional inspection: diameter just below screw head specification: ø 2.45 +/- 0.2 mm measured diameter: ø 2.36 mm; conforming device used: calipers ca592 because the lot number is unknown, a device history record (dhr) review could not be performed.A review of the current design drawing and the drawing revision at the time of manufacture was performed; no issues were identified.Based on the available information it is not possible to determine a definitive root cause for the complaint condition.It is possible that an excessive off-axis load was applied resulting in the complaint condition.A material review could not be performed because the lot number is unknown.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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
Patient outcome was stable.

• Brand Name: 2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7828276
• Report Number: 2939274-2018-53531
• Device Sequence Number: 19417334
• Product Code: HWC
• UDI-Device Identifier: 10886982143990
• UDI-Public: (01)10886982143990
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K113364
• 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): 08/13/2018

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: 202.216
• Device Catalogue Number: 202.216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 10/03/2018
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 90