MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REDUCTION FORCEPS POINTS SPEED LOCK 205

Model Number	399.78
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2021, patient underwent for a procedure.During a patella and ankle fracture our large point-to-point reduction clamp broke and the drill sleeves from both small frags at this facility weren't working properly.The spring inside both guides had gotten stuck and wouldn't compress.No fragments generated noted.There was 5 minutes of surgical delay noted.The procedure was successfully completed.No patient consequences noted.This complaint involves five (5) devices.This report is for (1) reduction forceps points speed lock 205.This is report 1 of 3 or complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was 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.
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.Investigation summary: the complaint device (reduction forceps points speed lock 205) was not received for investigation.A photo investigation was performed based on the photo provided.The image was reviewed, and the complaint condition is confirmed.The forceps appear to be missing the spindel holder and one of the spring screws that position the screw drive.A definite assignable root cause could not be determined based on the provided information.As the device was not returned, and as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.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: 399.78, lot number: 79p1252 (wo# 17315782), manufacturing site: tuttlingen, release to warehouse date: 26-jan-2021.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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.

• Brand Name: REDUCTION FORCEPS POINTS SPEED LOCK 205
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12972236
• Report Number: 2939274-2021-07020
• Device Sequence Number: 17256383
• Product Code: HTD
• UDI-Device Identifier: 10886982203052
• UDI-Public: (01)10886982203052
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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: 399.78
• Device Catalogue Number: 399.78
• Device Lot Number: 79P1252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5 NEUTR SLV ADAPT 3.5 NON-LCKNG DR GD; 3.5 NEUTR SLV ADAPT 3.5 NON-LCKNG DR GD; 3.5MM NON-LOCKING DRILL GUIDE; 3.5MM NON-LOCKING DRILL GUIDE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown