MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC WASHER 13.0MM; BOLT,NUT,WASHER

Model Number	219.99
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).No code available used to capture need to lengthen incision.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 a patient was implanted with three (3) 7.3mm cannulated screws and three (3) 13.0mm washers on (b)(6) 2017 to treat a sub capital hip fracture.Patient presented to emergency room on (b)(6) 2017 complaining of pain.X-rays showed fracture healed and one of the screws had cut out proximally.Patient underwent hardware removal on (b)(6) 2017.There were no reported issues with the washers or other two (2) screws.The surgeon easily removed the first screw and experienced difficulty removing the first washer.The incision was slightly extended in order to remove the washer.Once the incision was made, the surgeon easily removed the first washer and removed the two screws and two washers without issue.There was an approximate five minute surgical delay.Patient was not revised to any additional hardware, as the fractured healed.The procedure was completed successfully and the patient was reported to be stable.Pc-000057062 addresses the screw cut out and hardware removal.This report addresses the difficulty with removal of the washer and incision extension.Concomitant devices reported: 7.3mm cannulated screw, 16mm thread, stainless steel (partial part 208.8xx, lot number unknown, quantity 1), 7.3mm cannulated screw, 32mm thread, stainless steel (partial part 209.8xx, lot number unknown, quantity 1) and washers 13.0mm (part #: 219.99, lot number unknown, quantity 3).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Updated quantity for concomitants.Device was used for treatment, not diagnosis.
Event or Problem Description
Concomitant devices reported: 7.3mm cannulated screw, 16mm thread, stainless steel (partial part # 208.8xx, lot # unknown, quantity of 2), 7.3mm cannulated screw, 32mm thread, stainless steel (partial part # 209.8xx, lot # unknown, quantity of 1) and washers 13.0mm (part # 219.99, lot # unknown, quantity of 2).

• Brand Name: WASHER 13.0MM
• Common Device Name: BOLT,NUT,WASHER
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA
• MDR Report Key: 7086731
• Report Number: 2939274-2017-50156
• Device Sequence Number: 1079956
• Product Code: HTN
• UDI-Device Identifier: 10886982156297
• UDI-Public: (01)10886982156297(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAD
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 219.99
• Device Catalogue Number: 219.99
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Weight: 72