MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL TOP HAT TAP; BONE TAP, REUSABLE

Model Number	288203
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the affiliate in (b)(6) that pre-operatively to a shoulder repair procedure on (b)(6) 2021, it was observed that the handle on the top hat tap device was cracked.The same device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed a appropriate.H10 additional narrative: investigation summary: background: it was reported via complaint submission tool that the hospital notified that pre-operatively to a shoulder repair the top hat tap, combo screwdriver, and inline coracoid drill guide on the latarjet experience kit had cracked handles.The hospital stated the handle on the coracoid drill guide looks like someone has attempted to glue it back together.No surgical delay or patient consequences were reported.Investigation summary: the top hat tap (part #: 288203, lot #: 17k03) was received and evaluated at us cq.Upon visual inspection, the handle of the device was cracked.Hence, the reported condition could be confirmed.A definitive root cause cannot be determined for the reported problem.A manufacturing record evaluation was performed for the finished device [17k03] number, and no non-conformances were identified.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent to which this complaint is observed in the field.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.

• Brand Name: TOP HAT TAP
• Common Device Name: BONE TAP, REUSABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 12202694
• Report Number: 1221934-2021-02216
• Device Sequence Number: 4487270
• Product Code: LXH
• UDI-Device Identifier: 10886705026814
• UDI-Public: 10886705026814
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2021

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: 288203
• Device Catalogue Number: 288203
• Device Lot Number: 17K03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 08/18/2021; 08/31/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/19/2021; 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1