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	04/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the impactor tip broke during final impaction of the implant.Had backup, delay of less than 30 minutes.
Additional Manufacturer Narrative
A visual inspection of the returned device confirmed the stated failure mode.The device was cracked.The device also had numerous nicks and gouges in the surface, particularly around the fracture site.The device exhibits signs of extensive wear/usage.Plastics are vulnerable to brittle fractures due to impact over loading.A crack may have initiated during use or due to the heating and cooling associated with autoclaving.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 complaint will be reopened.We will continue to monitor for future complaints and investigate as necessary.

• 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: 8573925
• Report Number: 1020279-2019-01731
• Device Sequence Number: 16206808
• 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): 06/23/2019

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: 05/29/2019
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1