MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PERI-LOC SM FRAG INST & IMPLANT SET LID; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71170660
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Case (b)(4).
Event or Problem Description
It was reported that the device is peeling.Unknown when the incident occurred, of occurred a surgical delay and how the procedure finished.Patient injuries were not reported.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: PERI-LOC SM FRAG INST & IMPLANT SET LID
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11204269
• Report Number: 1020279-2021-00508
• Device Sequence Number: 4085736
• Product Code: LXH
• UDI-Device Identifier: 00885556015933
• UDI-Public: 00885556015933
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 08/24/2021

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 Model Number: 71170660
• Device Catalogue Number: 71170660
• Device Lot Number: 10HAV0003
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 08/24/2021
• Patient Sequence Number: 1