MAUDE Adverse Event Report: DEPUY MITEK LLC US RESTORE FEMAIMER OFFSET 8MM *EA; ORTHOPAEDIC IMPLANT AIMING/GUIDING BLOCK

Catalog Number	219358
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4) - incomplete.The lot number is currently unavailable.Investigation summary: the complaint device was received and evaluated.Visual observation confirms that the eyelet pin is stuck inside the femoral aimer and its distal and proximal ends are broken and missing.It was reported that the pin broke during drilling.The stuck pin was forced out to be inspected.The damaged pin had excessive amount of striation marks and it was slightly bent towards the distal end.The diameter of the pin was measured and was found to be per specification.Moreover, the aimer was inspected and no anomalies were found with it.Although this complaint can be confirmed, we cannot discern a root cause for this failure.A possible hypothesis is that the surgeon exerted excess side load on the instruments causing it to snap and get stuck inside the aimer.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.At this point in time, no further action is warranted.Should more information be provided in future regarding this complaint, the contents of the file will be updated.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.
Event or Problem Description
This is report 2 of 2 for the same event.It was reported by the sales rep reported that during an anterior cruciate ligament surgical procedure, it was observed that when drilling the disposable acl baypins w/eye.094x18", one of the pins broke off in their femoral aimer 8mm offset in the patient.The sales rep stated that they are unable to remove the broken pin from the device.The sales rep stated that there was no debris left in the patient.The sales rep reported that the surgeon completed the procedure by downsizing to a different size and drill.The sales rep reported that there were no patient consequences but there was a five minute delay in the case.The sales rep could not provide a lot number for the device but stated that the device is an older device.The device will be returning for evaluation.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Common Device Name: ORTHOPAEDIC IMPLANT AIMING/GUIDING BLOCK
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8142492
• Report Number: 1221934-2018-55592
• Device Sequence Number: 1746261
• Product Code: LXH
• UDI-Device Identifier: 10886705005987
• UDI-Public: 10886705005987
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2016

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 Catalogue Number: 219358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2016
• Initial Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1