MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.0MM SURESHOT LONG AO DRILL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	71692811
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, drill broke and the head of the drill was left in the femoral shaft medullary cavity.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, without the requested clinical information the root cause of the drill head breakage cannot be determined.The drill head is biocompatible however, the patient impact beyond possible micro-motion and/or migration, local irritation/discomfort cannot be determined though as it will likely stay in the medullary canal it will likely not cause any further issue.It has not been communicated if a revision surgery will be performed to remove the retained component.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: 4.0MM SURESHOT LONG AO DRILL
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8534351
• Report Number: 1020279-2019-01613
• Device Sequence Number: 11370437
• Product Code: OLO
• UDI-Device Identifier: 03596010648259
• UDI-Public: 03596010648259
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K100107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2026
• Device Catalogue Number: 71692811
• Device Lot Number: 16CNG0024
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/21/2019
• Supplement Report FDA Received Date: 10/18/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 78 YR