MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. HIP INSTRUMENT; OFFSET CUP IMPACTOR, MIS T8143

Catalog Number	803-11-103
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - while trying to insert the cup, the cup was lodged in the bone.The surgeon was trying to reseed the cup and in doing so the impactor threads broke off.
Additional Manufacturer Narrative
The reason for this complaint was to report the impactor threads breaking off.Based on the released date the instrument may have been in service for over 2.2 years.This event occurred during surgery near the patient.There was another suitable device available, the incident did cause a 20 minute delay in surgery, however, surgery was completed as intended.There was no risk to the patient noted and the instrument was inspected prior to surgery and was found to be acceptable.The impactor was returned to djo surgical on (b)(6) 2016; the broken threaded piece was not returned.A complaint database review showed previous complaints against this part, summary of complaints: 8 functional, 1 dull/worn, 3 locking mechanism damaged, 11 threads damaged/galled, 1 missing feature, 1 missing component, 23 broke/cracked/damaged, 2 hardware missing/lost.There were no indications that this instrument has a design or material deficiency.There have been no previous investigations against this lot number.An examination of the returned impactor confirmed that a portion of the threads have broken off (broken threaded piece not returned).The reported condition could possibly be a result of the parts not mating completely together, its extended usage, exposure high loads/impactions, or repeated use in many surgeries.Refer to instrument instructions for use (ifu 0400-0146 "recommendations for the care and handling for djo surgical instruments.The root cause of this event is attributable to damage incurred from prolonged use and through misuse or rough handling which surgical instruments are subjected to.This is not an event associated with a product failure, malfunction or issue.There are no indications that this instrument has a design or material deficiency therefore no containment of inventory is required.

• Brand Name: HIP INSTRUMENT
• Common Device Name: OFFSET CUP IMPACTOR, MIS T8143
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 6058002
• Report Number: 1644408-2016-00805
• Device Sequence Number: 360397
• Product Code: HWA
• UDI-Device Identifier: 00888912105033
• UDI-Public: (01)00888912105033
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2017

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: 803-11-103
• Device Lot Number: 2789308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2016
• Supplement Report FDA Received Date: 01/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR