MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM; APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT

Model Number	241.901
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: investigation flow: functional/device interaction.Visual inspection: the 3.5 lcp proximal hum pl-std 3h sft/90 (p/n: 241.901, lot number: 89p1948) was received at us cq.Visual inspection of the complaint device had no damage or issues observed.Functional test: a functional assessment was unable to be performed on the complaint device due to no mating devices being returned.The complaint was not able to be replicated.Dimensional inspection: a dimensional inspection was not performed since it was not applicable to the complaint condition.Document/specification review: (b)(4) (current and manufactured) was reviewed.No design issues or discrepancies were identified.The complaint is not confirmed.Investigation conclusion: this complaint is not confirmed as no functional test could be performed and no damage or issues were observed.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part number: 241.901-us, lot number: 89p1948, manufacturing site: (b)(4), release to warehouse: february 10, 2021.A manufacturing record evaluation was performed for the finished device lot number and no non-conformance's were identified.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, the patient underwent for a surgery.During open reduction internal fixation proximal humerus, plate was in situ with several locking screws in place proximally.While attempting to reduce the plate to the bone, the threaded locking towers would not stay engaged in the plate.Plate was removed, periarticular proximal humerus plate was used instead.The surgery was delayed for 10 minutes.The procedure was successfully completed.There were no patient consequences reported.Concomitant devices reported: unknown locking screws (part# unknown; lot# unknown; quantity: unknown).This complaint involves two (2) devices.This report is for (1) 3.5mm lcp® proximal humerus plate-standard 3h shaft/90mm.This report is 1 of 4 (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: 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.D7a: unknown.
Event or Problem Description
It was also reported that three (3) locking screws were involved in the most proximal of the three shaft holes.The surgeon was unable to get any of the screws to engage in the threaded portion of the plate.Those locking screws were later tested on a six-hole locking compression (lcp) plate and were verified to successfully lock into that plate.

• Brand Name: 3.5MM LCP PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM
• Common Device Name: APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11679907
• Report Number: 2939274-2021-01898
• Device Sequence Number: 3099675
• Product Code: KTW
• UDI-Device Identifier: 10886982167620
• UDI-Public: (01)10886982167620
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K011815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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: 241.901
• Device Catalogue Number: 241.901
• Device Lot Number: 89P1948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: LOCKING; UNK - SCREWS: TRAUMA; UNK - SCREWS: LOCKING; UNK - SCREWS: TRAUMA
• Patient Age: 67 YR