MAUDE Adverse Event Report: SMITH & NEPHEW, INC. WRENCH 10MM X 13MM

Catalog Number	71075900
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during procedure, metal was very soft and chipping at teeth of wrench 10mm x 13mm which causes the wrench to slip and slide off nuts/bolts that make it unusable.Length of wrench is too long to be used effectively.Surgery was resumed, with a changed in surgical technique.It is unknown if there was any delay.Patient was not harmed.
Event or Problem Description
It was reported that during an ex-fix procedure, metal was very soft and chipping at the teeth of wrench 10mm x 13mm which causes the wrench to slip and slide off nuts/bolts that make it unusable.Length of the wrench is too long to be used effectively.Surgery was resumed after a non-significant delay.It is unknown how the procedure was finished.Patient was not harmed.
Additional Manufacturer Narrative
H6: health effect - impact code b5: describe event or problem and h6: health effect - impact code.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual inspection of the returned devices did reveal the stated failure mode.Both of the devices were found to be chipped on the 10mm end along the wrench tip, rendering the devices inoperable.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.These devices are reusable instruments that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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 future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
Additional information: d4, h4 lot number, manufacturing date.

• Brand Name: WRENCH 10MM X 13MM
• Common Device Name: WRENCH
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15895568
• Report Number: 1020279-2022-04869
• Device Sequence Number: 5209795
• Product Code: HXC
• UDI-Device Identifier: 00885556783788
• UDI-Public: 885556783788
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup,Followup
• Report Date (Section B): 01/31/2023

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 Catalogue Number: 71075900
• Device Lot Number: 21ESC0034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 12/12/2022; 01/27/2023; 01/27/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 12/19/2022; 01/31/2023; 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown