MAUDE Adverse Event Report: DEPUY MITEK RESTORE TIB GDE/RACHET *EA; BONENAIL GUIDEWIRE

Catalog Number	219301
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2015
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.The complaint devices were received and evaluated.The returned ratcheting rail fits into the guide as intended.The returned tibial guide, rail and bullet were inspected for any anomalies.No anomalies were found with the tibial guide or the rail that would have contributed in the reported failure.The bullet was extremely worn and all the teeth at the distal end are bent.The returned pin was significantly bent in multiple locations and the eyelet piece was bent, which might have contributed in the incorrect drill alignment.The distal end of the pin was broken and stuck inside the bullet.No information was provided on how or when this damage to the pin has occurred.The reported failure can be confirmed, but it¿s not attributed to the tibial guide or rail.The damage to the teeth of the bullet would have caused the pin to get stuck inside the bullet, causing it to bend and break.Furthermore, no lot numbers were supplied for the tibial guide assembly 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.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.Udi: (b)(4) - incomplete.Depuy synthes has been informed that the lot number is not available.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
This is report 2 of 2 for the same event.It was reported from (b)(6) that during pre-surgery inspection at the warehouse, it was observed that the drill point pin device was broken inside the ratchet guide device.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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.Correction: upon further review of the complaint, it was determined that the reported malfunction with this device is unlikely to cause or contribute to serious injury or death if it were to recur.Therefore, this complaint is not reportable.If additional information should become available, a supplemental medwatch will be submitted accordingly.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7677458
• Report Number: 1221934-2018-50768
• Device Sequence Number: 848040
• Product Code: FZX
• UDI-Device Identifier: 10886705005567
• UDI-Public: 10886705005567
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2015

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: 219301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Initial Date Received by Manufacturer: 10/07/2015
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRILL DEVICE