MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONICAL TAP 7MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number	71369007
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during revision surgery of stem, while removing bone cement (very gently) from the canal, the distal part of the instrument was broken.A broken part was left in the canal, location confirmed by x-rays.As it was not possible to implant a long revision stem, a short one was used instead.There was a delay longer than 30 minutes reported.
Additional Manufacturer Narrative
The associated conical tap was not returned for evaluation.A clinical evaluation conducted during this investigation noted that without additional relevant clinical information or return of the broken instrument, the root cause of the reported failure cannot be determined.The post-operative condition of the patient is unknown at this time.As the location of the fragment cannot be confirmed, it is unknown whether micro-motion could occur.Therefore, the future impact to the patient cannot be determined.No further clinical assessment is warranted based on the limited details provided.The device was manufactured in 2011.Our investigation including a review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: CONICAL TAP 7MM
• 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: 8074436
• Report Number: 1020279-2018-02498
• Device Sequence Number: 244482
• Product Code: JDH
• UDI-Device Identifier: 03596010437631
• UDI-Public: 03596010437631
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2019

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: 71369007
• Device Lot Number: 11BSY0001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR