MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5 VA POSTLAT DHP 4H/RT/88-MEDIUM-S; PLATE,FIXATION,BONE

Model Number	02.117.204S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional product code : hwc.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 the surgery, the locking screw would not engage and locking into the plate.The surgery was completed successfully with 20-25 minutes delay.The patient condition was unknown.Concomitant device reported: unknown screwdriver (part# unknown; lot# unknown; quantity: 1).This complaint involves two (2) devices.This report is for (1) 2.7/3.5 va postlat dhp 4h/rt/88-medium-s.This report is 1 of 2 (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.H3, h4, h6: part: 02.117.204s, lot: 5l33446, supplier: (b)(4), release to warehouse date: july 23, 2019, expiry date: june 01, 2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the 2.7/3.5 va postlat dhp 4h/rt/88-medium-s was returned and received at us customer quality (cq).Upon visual inspection, no defects were observed on the plate.All the threads of the locking holes looks intact and no other defects was found on the plate.Functional test: the functional test cannot be performed at cq as no locking screws/mating screws were returned.Dimensional inspection: a dimensional inspection was not performed due to complex geometry of the plates/locking screw holes.Document/specification review: based on the date of manufacture, the current and latest drawings were reviewed.Investigation conclusion: the complaint condition was not confirmed for the 2.7/3.5 va postlat dhp 4h/rt/88-medium-s.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 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.D7: it is unknown if this single use device was reprocessed and reused.

• Brand Name: 2.7/3.5 VA POSTLAT DHP 4H/RT/88-MEDIUM-S
• 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: 11789961
• Report Number: 2939274-2021-02252
• Device Sequence Number: 3854894
• Product Code: HRS
• UDI-Device Identifier: 10886982036131
• UDI-Public: (01)10886982036131
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120717
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: 02.117.204S
• Device Catalogue Number: 02.117.204S
• Device Lot Number: 5L33446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/10/2021
• 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: UNK - SCREWDRIVERS; UNK - SCREWS: LOCKING; UNK - SCREWDRIVERS; UNK - SCREWS: LOCKING
• Patient Age: 59 YR