MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOX CHISEL; PRSTHSS,KNEE,FMRTBL,SM-CNSTRND,CMNTD,METAL/POLYMER

Model Number	71440373
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the box chisel end chipped during use in case.It was inside the patient.It is unknown how was the procedure completed.
Additional Manufacturer Narrative
Results of investigation: the device, intended for used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is chipped, damaged and has signs of wear and tear from use.According to clinical/medical investigation , a picture of the chipped chisel was provided and no further information has been forthcoming.I is still unknown what type of procedure was being preformed and if the chip fell into the patient or if all chips were recovered.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.The device was manufactured in 2011.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaints.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.

• Brand Name: BOX CHISEL
• Common Device Name: PRSTHSS,KNEE,FMRTBL,SM-CNSTRND,CMNTD,METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10262226
• Report Number: 1020279-2020-03127
• Device Sequence Number: 11479505
• Product Code: HRY
• UDI-Device Identifier: 00885556034965
• UDI-Public: 00885556034965
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

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: 71440373
• Device Catalogue Number: 71440373
• Device Lot Number: 11AM05927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 07/12/2020
• Supplement Report FDA Received Date: 10/15/2020
• 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