MAUDE Adverse Event Report: DEPUY MITEK LLC US INTRAFIXFAMILY TIBIAL SHEATHINSERTER; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Catalog Number	254618
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The lot number is unknown.
Event or Problem Description
It was reported by the sales rep via cst tool that during an acl reconstruction the intrafix inserter for 30mm sheath broke.It is unknown if the surgery was delayed due to the reported event.The procedure was successfully completed.It is unknown if fragments were generated.Patient status is unknown.It is unknown if any medical intervention was required or whether the patient was part of a clinical study.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.It was observed that the tip of the device had been broken off, which was received with the handle of the device.The device is reusable, and there is no lot number physically present on the device suggesting that the device must be at least four (4) years old per the revision history of the drawing.It is possible that the tip of the device was mishandled on a hard surface therefore causing it to break.However, given the information provided we cannot discern a definitive root cause for the reported failure.No lot numbers were supplied which precludes conducting a device history record (dhr) review.At this point, 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.Corrected data: report date initially reported as march 09, 2019 but should have been march 08, 2019.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: INTRAFIXFAMILY TIBIAL SHEATHINSERTER
• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8475734
• Report Number: 1221934-2019-56740
• Device Sequence Number: 1303477
• Product Code: LXH
• UDI-Device Identifier: 10886705013166
• UDI-Public: 10886705013166
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2019

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: 254618
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Received by Manufacturer: 03/09/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 04/25/2019
• Patient Sequence Number: 1