MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MICRORAPTOR DRILL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72204988
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Numbness (2415); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an arthroscopic hip surgery, the tip of a microraptor drill bit broke off in the bone on the first pass of the drill bit going in.The fragments were retained in the pelvis as retrieving would cause issue.The surgery was completed by using a back-up device in the previously drilled bone hole.Surgery was delayed about 10 min; nevertheless, the patient was not stated to be harmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported microraptor drill, used in treatment, has been returned for evaluation.Visual assessment of the drill confirmed the reported complaint.Approximately ½ inch of the drill head has been broken off and was not returned.The break area is angular in nature and shows signs of plastic deformation.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force placed on the drill during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.This case reports that during an arthroscopic hip surgery, the tip of a microraptor drill bit broke off in the bone on the first pass of the drill bit going in.Per e-mail communication the fragments were retained in the pelvis.The surgery was completed by using a back-up device in the previously drilled bone hole.No patient injuries are be reported due to the additional surgical time.Based on the limited information provided the root cause of the reported microraptor drill tip breakage cannot be determined.It is unclear if the instructions for use was adhered to, it has precautionary statements and instructions in regards to avoid damage or non-functionality, and this includes avoiding excessive force on the drill during use.The needle tip is made of astm f2063 nitinol which is a biocompatible material however, since the needle tip is part of a surgical device it is not approved for implantation.Since the retained drill tip was left in the bone, migration is unlikely.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ¿patient information ¿surgical procedure/post-operative care review ¿device labeling (including technique guides, ifus, etc.) this case reports that during an arthroscopic hip surgery, the tip of a microraptor drill bit broke off in the bone on the first pass of the drill bit going in.Per e-mail communication the fragments were retained in the pelvis.The surgery was completed by using a back-up device in the previously drilled bone hole.No patient injuries are be reported due to the additional surgical time.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.The microraptor drill was returned for evaluation and the results confirmed that approximately ½ inch of the drill head has been broken off.Material composition: the microraptor drill tip material is nitinol per astm f2063 which is used in several implantable medical devices.Conclusion: based on the limited information provided the root cause of the reported microraptor drill tip breakage cannot be determined.It is unclear if the ifu was adhered to, it has precautionary statements and instructions in regards to avoid damage or non-functionality, and this includes avoiding excessive force on the drill during use.The needle tip is made of astm f2063 nitinol which is a biocompatible material however, since the needle tip is part of a surgical device it is not approved for implantation.Since the retained drill tip was left in the bone, migration is unlikely.No further clinical/medical assessment is warranted at this time.Approved by (b)(6), md, (b)(6) 2020.
Event or Problem Description
It was reported that, during an arthroscopic left hip surgery performed on (b)(6) 2020, the tip of a microraptor drill bit broke off in the bone on the first pass of the drill bit going in.The fragments were retained in the pelvis as retrieving would cause issue.The surgery was completed by using a back-up device in the previously drilled bone hole.Surgery was delayed about 10 min.An additional surgery was performed on (b)(6) 2020, and the drill was successfully removed.Currently, the patient still has numbness, but this condition is related to the original diagnose.

• Brand Name: MICRORAPTOR DRILL
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 9782387
• Report Number: 1219602-2020-00458
• Device Sequence Number: 2778468
• Product Code: MAI
• UDI-Device Identifier: 00885556710296
• UDI-Public: 00885556710296
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K180361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2023
• Device Model Number: 72204988
• Device Catalogue Number: 72204988
• Device Lot Number: 50769947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 02/07/2020; 09/23/2025
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 04/17/2020; 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female