MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 7.5MM; BIT, SURGICAL

Model Number	72204041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during an acl reconstruction procedure, internal to the patient, the retrograde drill broke when drilling a bone hole.All broken pieces were removed from the patient.The procedure was completed with a significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided images revealed that the drill tip and its internal mechanisms had broken off of the main device.There appeared to be some deformation on the metal sides of the tip.A visual inspection revealed that the device was returned with all complementary components.The broken pieces of the drill were returned in a small bag.It appeared that the drill tip, rotating inner cutter, and inner wire had broken off.There was minimal debris, but there was biting and deformation present in the metal.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found the following warnings and precautions related to the reported failure: read these instructions completely prior to use.The cannulated power drill must always be set to forward when drilling tunnels and retrograde-drilling sockets.The device may fail if the cutting blade is not at full rotational speed prior to contacting bone and throughout retrograde drilling.Prior to deploying the cutting blade, ensure that the guide wire is retracted within the groove approximately 1.5 inches (38 mm) within the retrograde drill shaft and is not in the drill head window.The groove in the guide wire provides tactile feedback that it is retracted to the proper position.This will prevent possible device failure.The device is intended to drill in a retrograde motion only when cutting blade is deployed.Antegrade drilling while the cutting blade is deployed may result in device failure.Where appropriate, tunnel and socket drilling techniques should be determined by surgical circumstance and the experience of the surgeon.Use of this device in excessively hard bone may cause failure of the device.Use only the smith & nephew devices provided in the retrograde drill kit.As with any surgical instrument, careful attention must be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.A clinical investigation concluded that no relevant supporting clinical information was provided.The patient's condition was unknown and the patient impact beyond the reported extended surgical time could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment could not be performed.Should any additional clinical information be provided this complaint will be re-evaluated.The complaint was confirmed.Factors that could have contributed to the reported event include excess force or bending on the device, inconsistent rotational speed, use of drill set to reverse, antegrade drilling when the cutting blade is deployed, or use in excessively hard bone.No containment or corrective actions are recommended at this time.

• Brand Name: RETROGRADE DRL 7.5MM
• Common Device Name: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11170236
• Report Number: 1219602-2021-00123
• Device Sequence Number: 17034900
• Product Code: GFG
• UDI-Device Identifier: 00885554037708
• UDI-Public: 00885554037708
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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 Expiration Date: 10/04/2024
• Device Model Number: 72204041
• Device Catalogue Number: 72204041
• Device Lot Number: 4937163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Received by Manufacturer: 12/24/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 02/24/2021
• 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