MAUDE Adverse Event Report: DEPUY MITEK LLC US GRAFT SIZING BLOCK, 5-12MM; ORTHOPAEDIC GRAFT SIZER

Model Number	219444
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional 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 during an anterior cruciate ligament reconstruction procedure on (b)(6) 2021, it was observed that the graft sizer device was broken.Another like 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.H10 additional narrative: investigation summary: according to the information received, it was reported that when opening the instrument box, it was evident that the graft sizer is broken.The device was returned to mitek for evaluation.Mitek then conducted visual inspection of device received and photo provided by the customer.Upon visual inspection, the observations revealed that the device was dirty and had scratches; it appeared to be heavily used.Also, it was identified that the device was cracked.The photo provided by the customer showed the same condition found in the physical evaluation.A manufacturing record evaluation was performed for the finished device [1607001] number, and no non-conformances were identified.Based on the visual evaluation of the physical device, this complaint can be confirmed.From the lot number provided on the device, it was noted that this device is from 2016 and possibly been heavily used.The device might have come in contact with other metal instruments during handling causing this kind of nicks and marks.The crack in the device is possibly a result of mishandling during storage or cleaning.As per ifu-106674, visually inspect the instrument and check for damage and wear prior to use.Use a properly maintained and cleaning process.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.
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.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.H6.Medical device problem code has been updated to reflect the correct information.

• Brand Name: GRAFT SIZING BLOCK, 5-12MM
• Common Device Name: ORTHOPAEDIC GRAFT SIZER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11447259
• Report Number: 1221934-2021-00785
• Device Sequence Number: 4049191
• Product Code: LXH
• UDI-Device Identifier: 10886705006502
• UDI-Public: 10886705006502
• Combination Product (Y/N): N
• 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): 02/23/2021

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: 219444
• Device Catalogue Number: 219444
• Device Lot Number: 1607001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 05/20/2021; 05/24/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 05/21/2021; 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1