MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FM HEAD REPL PLAS TIP; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number	71362807
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery a part of the impactor tip broke off during impaction of the femoral head.No pieces fell inside the patient.No injury reported, a delay below 30 min was reported.A s&n backup device was used to finish the surgery.
Additional Manufacturer Narrative
The associated complaint device was returned for evaluation.The visual inspection confirms the impactor tip is broken/missing pieces, which were not returned.Also the device shows signs of significant usage and wear.It¿s unknown when the device was manufactured.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: FM HEAD REPL PLAS TIP
• Common Device Name: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9318682
• Report Number: 1020279-2019-04031
• Device Sequence Number: 607326
• Product Code: JDH
• UDI-Device Identifier: 00885556025871
• UDI-Public: 00885556025871
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2019

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: 71362807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 11/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1