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	Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Date of event: unknown.Original implant date was performed on (b)(6) 2016 after a patient suffered a gunshot wound.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.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2016 after a patient suffered a gunshot wound where one (1) 2.4 mm locking compression plate (lcp), four (4) 7.3 mm cannulated screws, four (4) washers, two (2) 2.4 mm locking screws, and one (1) 2.4 mm cortex screw was implanted.Post-operatively, patient returned to surgery due to a nonunion.Revision surgery was performed on (b)(6) 2018, where all previous implants were removed and patient received a total hip replacement.There was no surgical delay and surgery was completed successfully.Patient status was reported as ok.This complaint involves 12 parts (four unk-7.3 mm cannulated screws, four washers, one plate, two unk-2.4 m locking screws and one unk-2.4 mm cortex screw) this report is for (1) washer 13.0 mm.This report is 6 of 8 for (b)(4).

• 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 19380
• MDR Report Key: 7329543
• Report Number: 2939274-2018-51000
• Device Sequence Number: 18871896
• Product Code: HTN
• UDI-Device Identifier: 10886982156297
• UDI-Public: (01)10886982156297(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: PREADM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2018

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: 02/12/2018
• Initial Report FDA Received Date: 03/09/2018
• 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: 46 YR
• Patient Weight: 76