MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CANNULATED SCREW PARTIALLY THREADED/52MM; SCREW, FIXATION, BONE

Model Number	214.552
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: reporter is synthes sales consultant.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 during an unknown trauma procedure performed on (b)(6) 2019, the thread of a 52mmx4.5mm cannulated screw (partially threaded) came unraveled and broke off into the bone of a patient upon insertion of a guide wire.Fragments were generated, and it was unknown if they were removed easily.There was a surgical delay of five (5) minutes.Another screw was used to complete the procedure.Procedure was completed successfully.There was no patient consequence reported.Concomitant device: unknown guide wire (part # unknown, lot # unknown, quantity 1).This report is for one (1) 4.5mm cannulated screw partially threaded.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.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: the 4.5 mm cannulated screw partially threaded/ 52 mm (part # 214.552, lot # unknown) was received at us cq with part of the screw thread unraveled.X-rays were sent to us cq and it was confirmed that the threads peeled intraoperatively.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional inspection: dimensional analysis was completed, the outer diameter of the threaded shaft, measured and is within specification based on relevant drawing.Document/specification review: the relevant drawing(s) was reviewed; a dhr review could not be performed since the lot number is unknown.A dhr file could not be found under part 214.552/lot 1605111 combination.A visual inspection at cq was performed and a lot number could not be identified.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.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 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: 4.5MM CANNULATED SCREW PARTIALLY THREADED/52MM
• 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: 8511597
• Report Number: 2939274-2019-57452
• Device Sequence Number: 13898324
• Product Code: HWC
• UDI-Device Identifier: 10886982154224
• UDI-Public: (01)10886982154224
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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: 214.552
• Device Catalogue Number: 214.552
• Device Lot Number: 1605111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/13/2019
• Patient Sequence Number: 1