MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC FLEX SFT CONNECTOR FOR USE JACOBS CHUCK; REAMER

Model Number	351.16J
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Device evaluated by mfr and manufacture date: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 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
Device report from synthes reports an event in usa as follows: it was reported that on jun 1, 2022, during tna tibial nail case, the flex sft connector for use jacobs chuck would not fit into a stryker power jacob's chuck.Then it was found that the base of the item was triangular in shape which is different than all the other ones.Same part number, just looks like the item is defected.The difference between a normal one and the defective one can be seen.The defective one has a triangular shape base.Each screw was put in by hand to finish the case.There was a surgical delay of 5 minutes.Surgery completed successfully.Patient consequence is unknown.Concomitant device reported: tibial nail-advanced / 10 315 / sterile (part: 04.043.225s; lot: 589p569; quantity: 1).Unk - screws: nail distal locking (part# unknown; lot# unknown; quantity: unknown).This complaint involves one (1) device flex sft connector for use jacobs chuck.This is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: investigation summary :the photo was returned to depuy synthes for evaluation.Visual analysis of the photo revealed that the flex sft connector for use jacobs chuck (product code: 351.16j) had no defect found on it.There is no enough evidence on the pictures provided to confirm reported allegation.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for flex sft connector for use jacobs chuck (product code: 351.16j).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 : the device lot number is unknown, therefore a device history review could not be performed.If more information become available, the record will be re-assessed.
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: d4: lot, expiration date.H3, h4, h6: part # 351.16j, lot # l376739, manufacturing site: werk bettlach, release to warehouse date: 20 apr 2017.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The customer reported the flex sft connector for use jacobs chuck would not fit into a stryker power jacob's chuck.Then it was found that the base of the item was triangular in shape which is different than all the other ones.The repair technician reported chuck sleeve unable to move freely.Product was machine manufactured, cut on top of the etch lettering.Etch unreadable is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is etch unreadable.The item will be forwarded to customer quality.The evaluation was confirmed.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: FLEX SFT CONNECTOR FOR USE JACOBS CHUCK
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14853114
• Report Number: 2939274-2022-02405
• Device Sequence Number: 5563323
• Product Code: HTO
• UDI-Device Identifier: 10886982193742
• UDI-Public: (01)10886982193742
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2022

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: 351.16J
• Device Catalogue Number: 351.16J
• Device Lot Number: L376739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 07/05/2022; 08/02/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 07/27/2022; 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TIBIAL NAIL-ADVANCED / 10 315 / STERILE; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Sex: Unknown