MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC T-HANDLE WITH QUICK COUPLING; TAP, BONE

Model Number	311.44
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 (b)(4) as follows: it was reported that during a procedure on (b)(6) 2021, the screwdriver shaft and t-handle are jammed one into the other and cannot be disassembled.There was a two (2) minutes surgical delay.The procedure was successfully completed with the use of a replacement screwdriver.No patient consequences reported.This report is for one (1) t-handle with quick coupling.This is report 2 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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 number and expiration date updated.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.H3, h4, h6- the overall complaint was confirmed.The potential cause for the device interaction condition could be due to the incorrect pairing of the devices.No definitive root cause could be determined based on the provided information.Nc was generated to address the incorrect tolerance of the no go pin.However, the nc is not relevant to the complaint condition and could have not contributed to the device interaction issue.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 : product code # 311.44 , synthes lot # h372980, supplier lot #: h372980, released to warehouse: 12feb2018, supplier : (b)(4).Review of the device history record(s) showed that there are potential issues during the manufacture of the product that 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.

• Brand Name: T-HANDLE WITH QUICK COUPLING
• Common Device Name: TAP, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12728214
• Report Number: 2939274-2021-06390
• Device Sequence Number: 1559086
• Product Code: HWX
• UDI-Device Identifier: 10886982187413
• UDI-Public: (01)10886982187413
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2021

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: 311.44
• Device Catalogue Number: 311.44
• Device Lot Number: H372980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 12/06/2021; 12/09/2021
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 12/06/2021; 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2018
• 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: SCRDRIVER SHAFT 4.5/5 T25 SELF-HOLD F/AO; SCRDRIVER SHAFT 4.5/5 T25 SELF-HOLD F/AO.
• Patient Sex: Unknown