MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL INLINE CORACOID DRILL GUIDE; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Model Number	288200
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 inline coracoid drill guide 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 as appropriate.Inspection of device provided by customer.Visual observations revealed that the device had marks of wear indicating it was heavily used.Also, the laser marks was slightly faded.It was found with scratches and some areas of the handle were cracked.A manufacturing record evaluation was performed for the finished device [16j01] number, and no non-conformances were identified.According with the visual inspection results, this complaint can be confirmed.It is determined that the reusable instrument is worn from repeated use and servicing, this failure can be attributed to normal field wear; as well as to blunt force impact/ heavily use.As per ifu, the precautions for this type of device consist to inspect the condition of the device prior to use.This device can damage, worn or bent; therefore, when this occurs it need to replace.Also, the instrument life is generally determined by the wear or damaged from handling or surgical use.Inspect the instruments before use for integrity and compatibility in order to ensure proper functionality and safety.It is important to follow the instructions for cleaning and sterilization process.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history lot: a manufacturing record evaluation was performed for the finished device [16j01] number, and no non-conformances were identified.
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: 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.

• Brand Name: INLINE CORACOID DRILL GUIDE
• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 12202696
• Report Number: 1221934-2021-02217
• Device Sequence Number: 12027186
• Product Code: LXH
• UDI-Device Identifier: 10886705026784
• UDI-Public: 10886705026784
• 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: 288200
• Device Catalogue Number: 288200
• Device Lot Number: 16J01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 08/17/2021; 08/23/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/18/2021; 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1