MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 TI LCP SUP CLAV PL/7 HOLES/RT/100; PLATE, FIXATION, BONE

Model Number	04.112.082
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Photo investigation: the device was not returned.A photo-investigation was performed on the images/radiographs received.Upon inspecting the images/radiographs provided, no product issues/defects were identified.The root cause for the reported event cannot be determined from the available information.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition is not being confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot: part # 04.112.082, synthes lot # h769447, supplier lot # n/a, release to warehouse date: 01 nov 2018, manufacturing location: (b)(4).No ncr's were generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 on (b)(6) 2021, the patient underwent removal of titanium locking compression plate (lcp) superior clavicle plate, six (6) unknown cortex screws, and one (1) unknown cancellous screw due to nonunion.The patient outcome was unknown.This complaint involves eight (8) devices.This report is for one (1)3.5 ti lcp sup clav pl/7 holes/rt/100.This is report 1 of 8 for complaint (b)(4).

• Brand Name: 3.5 TI LCP SUP CLAV PL/7 HOLES/RT/100
• 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: 12675245
• Report Number: 2939274-2021-06234
• Device Sequence Number: 1454873
• Product Code: HRS
• UDI-Device Identifier: 10886982102904
• UDI-Public: (01)10886982102904
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K111540
• 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): 09/24/2021

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: 04.112.082
• Device Catalogue Number: 04.112.082
• Device Lot Number: H769447
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/21/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: 2.7 MM CORTEX; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: 4.0 MM CANCELLOUS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR