MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG PIGALILEO NAV PAC SPEED-PINS 3.2 65 (6X); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75009338
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after surgery had been performed, the post-op x-rays showed that the tip of the drill pin had snapped inside of the tibia and is still in situ.It is unknown if a revision surgery will be performed to retrieve the piece.It is also unknown the current status of the patient.
Additional Manufacturer Narrative
Results of investigation: it was reported that the tip of a drill speed pin (75009338) snapped inside the tibia.The tip was left in situ, as it can be seen on the post operative x-rays.The batch number of the device in question, used in treatment, was not reported, and no additional information related to the case was received upon request.A batch related product history review could not be conducted.A complaint history review showed only this current complaint for the part in scope since 2017.The ifu (lit.No.12.24, ed.07/10) states that the all instruments may only be used in their original condition.Before used the functionality of surgical instruments should be checked.The risk of a broken pin is covered through our risk management files.A thorough medical assessment cannot performed, as no information was received.However, it is stated that the potential for corrosion and local irritation/migration of the pin-tip fragment cannot not be ruled out.The device is neither manufactured nor intended for implantation, no long-term exposure data is available.The root cause for the breakage of the tip cannot be determined after investigation.Regarding the part, further actions are not deemed necessary.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor this part for further similar issues.

• Brand Name: PIGALILEO NAV PAC SPEED-PINS 3.2 65 (6X)
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11112561
• Report Number: 9613369-2021-00002
• Device Sequence Number: 17046276
• Product Code: LXH
• UDI-Device Identifier: 07611996100525
• UDI-Public: 07611996100525
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2021

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: 75009338
• Device Catalogue Number: 75009338
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 04/17/2021
• 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: Other