MAUDE Adverse Event Report: DEPUY MITEK LLC US RESTORE FEMAIMER OFFSET 6MM *EA; ORTHOPAEDIC IMPLANT AIMING/GUIDING BLOCK

Model Number	219356
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Incomplete.The lot number was unknown.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 sales rep in (b)(6) that during an anterior cruciate ligament reconstruction procedure on (b)(6) 2021, it was observed that the restore femoral aimer 6 mm offset was scouring drill tip passing pin (that comes in acl disposable kit) during drilling that metal fragments were created.The procedure was completed using normal technique 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: 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.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 - according to the information provided, it was reported that during an acl reconstruction, an anteromedial femoral aimer 6.5mm was damaged inside the shaft.Surgeon was drilling with the 2.4mm drill pin from the rigidloop disposable.When drilling there was metal debris coming from the drill bit.Surgeon thinks drill guide may be bent.Metal particle was removed using the arthroscopic shaver and procedure was completed the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received provided by customer.Visual observation showed that the markings on the shaft have faded.From the appearance of the device, it can be determined that the device is worn.The handle distal revealed that the device had been heavily used as striations on the metal surface, it seems to lose the metal shape.This complaint can be confirmed.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.The possible root cause for condition can be attributed when the device being dropped/ mishandled on hard surface causing the damage.For the damage in the metal surface can be related when the device being dropped or hitting other metal instruments or excess force being exerted while use, as well as rough use during a long time ago.As per ifu, inspect for damage prior to use.Replace a damaged, worn or bent instrument.End of useful instrument life is generally determined by wear or damage from handling or surgical use.Clean instruments as soon as possible after use and clean delicate instruments separately from other instruments.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.

• Common Device Name: ORTHOPAEDIC IMPLANT AIMING/GUIDING BLOCK
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11872085
• Report Number: 1221934-2021-01636
• Device Sequence Number: 922584
• Product Code: LXH
• UDI-Device Identifier: 10886705005963
• UDI-Public: 10886705005963
• 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): 05/10/2021

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: 219356
• Device Catalogue Number: 219356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 07/22/2021; 07/28/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 07/23/2021; 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1