MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ORTHOMATCH TIB-INSERT IMPLANT IMPACTOR; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Model Number	71442171
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an anthem tka procedure, the orthomatch tibial-insert implant impactor broke during actual implant impaction.The device was inside the patient.It is unknown how the procedure continued.There were no delays and no injuries reported.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this case reports that he orthomatch tibial-insert impactor broke during implant impaction.However per email communication, the broken part fell off of the cutting block and all pieces were recovered.There was no patient injury, delays or other complications reported, and the patient is recovering well.Therefore, no further assessment is warranted.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.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes 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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: ORTHOMATCH TIB-INSERT IMPLANT IMPACTOR
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10232514
• Report Number: 1020279-2020-02917
• Device Sequence Number: 18981321
• Product Code: JWH
• UDI-Device Identifier: 00885556497104
• UDI-Public: 00885556497104
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• PMA/510(K) Number: K142807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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: 71442171
• Device Catalogue Number: 71442171
• Device Lot Number: 15JBG0039
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 05/26/2021
• 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
• Patient Weight: 70