MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMALL SLAP HAMMER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71367541
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a r3 slaphammer broke intraoperative.No items were left in patient, no harm was done to the patient and no delay was reported.S+n backup was available, but not needed.The procedure was completed using the same device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirms the threaded tip of the device is broken off.The broken piece was not returned with the device.The device was manufactured in 2018 and it shows signs of significant wear/usage.A medical investigation was conducted and per complaint details, the r3 shell impactor and a r3 slap-hammer broke intraoperatively.However, the procedure was reportedly completed with the same devices without retained foreign bodies, patient harm, and/or surgical delay and although available, the s+n backup was not needed.Per the product evaluation, the device exhibited signs of significant wear/ usage.Since no patient impact/injury/harm was alleged, no further medical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaint for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident.A review of risk management files found that the reported failure was documented appropriately.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: SMALL SLAP HAMMER
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10242418
• Report Number: 1020279-2020-02986
• Device Sequence Number: 14053087
• Product Code: JDG
• UDI-Device Identifier: 03596010402738
• UDI-Public: 03596010402738
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71367541
• Device Catalogue Number: 71367541
• Device Lot Number: 18JSY0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 11/26/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 11/06/2020
• 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: Required Intervention