MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN F/T BRCH SZ 16; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71366716
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a thr, the size 16 broach connector broke while the surgeon was trying to take out the broach stem after trailing.The piece that connects to the broach handle broke off and the broach stem remained in the patient¿s femur.The surgeon was able to make a small incision and remove the broach stem with a bone hook.There was a delay reported of 10 min.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The connection post on the device fractured off and was not returned.The device was manufactured in 2001 and exhibits signs of extensive wear / usage.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.The medical investigation concluded that, per product evaluation, the approximately 18-year-old device exhibits signs of extensive wear / usage.It was communicated that the broach stem was removed in its entirety, within a 10-15 minute surgical extension, with no harm to the patient, and a ¿good outcome with the surgery¿.No patient harm resulted and no foreign body was retained; therefore, no further medical assessment is warranted at this time.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: SYN F/T BRCH SZ 16
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9216088
• Report Number: 1020279-2019-03699
• Device Sequence Number: 13539460
• Product Code: JDI
• UDI-Device Identifier: 03596010429698
• UDI-Public: 03596010429698
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2011
• Device Catalogue Number: 71366716
• Device Lot Number: 01BM07330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention