MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CORACOID OFFSET PIN; BONENAIL GUIDEWIRE

Model Number	288206
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).
Event or Problem Description
It was reported via complaint submission tool that during a shoulder repair, while using a coracoid offset pin, the surgeon noticed the offset pin on the coracoid drill guide was bent.Surgeon had to bent the pin back to normal to complete procedure.No surgical delay or patient consequences reported.
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: correction: a1: patient identifier: the patient identifier was inadvertently missed on the initial report and has been updated accordingly.Additional information: h6: method codes: a manufacturing record evaluation was performed for the finished device [16f01] number, and no non-conformances were identified.D10, 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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: investigation summary : the device was received and inspected at cq.It was noticed that the device's distal pin was bent.Hence, the complaint is confirmed.While no definitive root cause could be determined, it is possible the device encountered unintended forces during its use.Ta manufacturing record evaluation was performed for the finished device [16f01] number, and no non-conformances were identified.Here is no indication that a design or manufacturing issue has caused the issue.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: CORACOID OFFSET PIN
• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10420438
• Report Number: 1221934-2020-02246
• Device Sequence Number: 11507154
• Product Code: LXH
• UDI-Device Identifier: 10886705026845
• UDI-Public: 10886705026845
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2020

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: 288206
• Device Catalogue Number: 288206
• Device Lot Number: 16F01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 08/25/2020; 09/21/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 09/11/2020; 09/22/2020
• Patient Sequence Number: 1