MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GLENOID DRILL GUIDE LONG BULLET; ACCESSORIES, ARTHROSCOPIC

Model Number	71935462
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a acl surgery while the instrument was inside of the patient, the tip of the glenoid drill guide long bullet is flared, causing it to catch on soft tissue and not go in straight and correct.The surgeon had to redrill, which made a larger hole and cannulated drill was not as secure in position.The procedure was successfully completed without delay using the same device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not received for evaluation and the reported event could not be confirmed.The shipping information was provided and all efforts were made to locate the device but we have no evidence that it was ever received by the complaint investigation team for evaluation.The clinical/medical investigation concluded that, no relevant clinical information was provided for inclusion for this investigation; therefore, a thorough medical investigation cannot be rendered, nor can the clinical root cause of the reported issue cannot be determined.Consequently, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional medical information be provided, this complaint will be re-assessed.A review of complaint history did not reveal additional complaints for the listed device.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of 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.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the glenoid drill guide long bullet confirms the tip of the device is broken off.The broken piece was not returned.The device show signs significant wear and use.A medical investigation was conducted and confirms no relevant clinical information was provided for inclusion for this investigation; therefore, a thorough medical investigation cannot be rendered, nor can the clinical root cause of the reported issue cannot be determined.Consequently, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional medical information be provided, this complaint will be re-assessed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GLENOID DRILL GUIDE LONG BULLET
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11962752
• Report Number: 1020279-2021-05058
• Device Sequence Number: 17082398
• Product Code: NBH
• UDI-Device Identifier: 00885556660003
• UDI-Public: 00885556660003
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup,Followup
• Report Date (Section B): 10/19/2021

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: 71935462
• Device Catalogue Number: 71935462
• Device Lot Number: 18CTN0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 08/16/2021; 10/19/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 08/17/2021; 09/22/2021; 10/19/2021
• 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: Required Intervention