MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TIN 5MM X 45MM SHORT HALF PIN; PIN, FIXATION, THREADED

Model Number	71065458
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	12/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a trauma surgery, the tin 5mm x 45mm short half pin broke inside the patient's bone when tightening.The surgeon used the set of the broken pin to remove the half pin and it took around an hour to get out the broken piece.The procedure was finished with a competitor's device.Patient was not harmed beyond the issue reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was found to be fractured into two pieces, rendering the device inoperative.The device shows signs of extensive use.Both pieces were returned.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.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 and instructions for use document 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.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file, include but not limited to excessive forces applied to implant.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.Internal complaint reference: (b)(4).

• Brand Name: TIN 5MM X 45MM SHORT HALF PIN
• Common Device Name: PIN, FIXATION, THREADED
• 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: 13191902
• Report Number: 1020279-2022-00119
• Device Sequence Number: 12258220
• Product Code: JDW
• UDI-Device Identifier: 03596010487315
• UDI-Public: 03596010487315
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K023134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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: 71065458
• Device Catalogue Number: 71065458
• Device Lot Number: 19LNX0007
• 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: 12/21/2021
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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