MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LCP ONE-THIRD TUB PL COLLAR 8 H/93; PLATE,FIXATION,BONE

Model Number	441.381
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # : (b)(4).Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).Investigation summary.Product was not returned.Based on the information available, it has been determined that no corrective and 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.Device history lot (b)(6) 2021 (b)(6).Part number: 441.381 lot number: 7360455 part manufacture date: apr 25, 2013 manufacturing location: (b)(4).Part expiration date: n/a.Nonconformance noted: (b)(4).Dhr record review: a review of the device history record revealed one nonconformance (ncr) written against this lot of ti lcp one-third tubular plate with collar 8 holes/93mm.(b)(4) was initiated for an oversized w1 feature.The issue was found at the subsequent final inspection operation.The order was dispositioned for a 100% check for conformance to the w1 feature and to scrap any non-conforming parts.Two parts were found to be non-conforming and were subsequently scrapped.Since all non-conforming parts were scrapped and the remainder conform, (b)(4) is not relevant to this complaint.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Device history review: apr 13, 2021 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 on (b)(6) 2021, an unknown hardware removal procedure was performed for unknown reason.It is unknown how the procedure was completed.It is unknown if there was a surgical delay.Patient outcome was unknown.This complaint involves thirteen (13) devices.This report is for (1) ti lcp one-third tub pl collar 8 h/93 this report is 1 of 11: (b)(4).Related product complaint: (b)(4).

• Brand Name: TI LCP ONE-THIRD TUB PL COLLAR 8 H/93
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11716694
• Report Number: 2939274-2021-02036
• Device Sequence Number: 3192381
• Product Code: HRS
• UDI-Device Identifier: 10886982221841
• UDI-Public: (01)10886982221841
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K011335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

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: 441.381
• Device Catalogue Number: 441.381
• Device Lot Number: 7360455
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5 TI LCKNG SCR SLF-TPNG SD RECESS 14; 3.5 TI LCKNG SCR SLF-TPNG SD RECESS 18; 3.5 TI LCKNG SCR SLF-TPNG SD RECESS 20; 3.5MM TI CORTEX SCREW SELF-TAPPING 14MM; 3.5MM TI CORTEX SCREW SELF-TAPPING 16MM; 3.5MM TI CORTEX SCREW SELF-TAPPING 18MM; 3.5MM TI CORTEX SCREW SELF-TAPPING 20MM; 4.0 TI CANCELLOUS SCREW FULLY THRD/20; 4.0 TI CANNULATED SCREW SHORT THREAD/40; WASHER 7.0MM
• Outcome Attributed to Adverse Event: Required Intervention