MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN DRILL PIN AND WIRE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number UNKNOWN

Device Problems Break (1069); Material Separation (1562)

Patient Problems Nerve Damage (1979); No Information (3190)

Event Date 07/02/2020

Event Type  Injury  

Event Description

It was reported that during a hip labrum repair surgery, the drill bit broke in the bone, the doctor decided to leave the broken tip in the bone.Week or so later the patient had an mri ad realized that the drill bit came out of the bone and was under the muscle in the hip.The patient has had all kinds of nerve issues due to the second surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Internal complaint reference (b)(4).The reported device, used in treatment, was not returned to the designated complaint facility for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.Insufficient product identification information was provided and thus a manufacturing record review, complaint history review, instructions for use review and risk management review could not be conducted.Attempts to obtain medical documents were unsuccessful and thus a thorough medical investigation was not performed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

Event Description

It was reported that during a hip labrum repair surgery, the drill bit broke in the bone, the doctor decided to leave the broken tip in the bone at that time.Week or so later the patient had an mri and realized that the drill bit came out of the bone and was under the muscle in the hip.The patient has had all kinds of nerve issues due to the second surgery.An additional surgery was performed, and the drill was successfully removed.Currently, the patient still has numbness but this condition is related to the original diagnose.

Manufacturer Narrative

Internal complaint reference: (b)(4).H10 h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported event.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.Insufficient product identification information was provided, and thus, an instructions for use review could not be conducted.Insufficient product identification information was provided, and thus, a risk management review could not be conducted.A complaint history review concluded this was an isolated event.The reported operative findings with the use of fluoroscopic imaging on (b)(6) 2020, revealed the drill bit fragment that was trapped under the periosteum, confirming the breakage of the drill tip.However, without the return of the device for evaluation, a definitive clinical root cause of the reported breakage could not be determined.According to the report, the patient continues to experience nerve issue due to the second surgery.However, based on the information provided, the patient¿s symptoms (numbness and pain) are unchanged from the original physical assessment prior to the primary surgery.Therefore, the causal relationship between the s&n device and the reported issue cannot be confirmed.Since this issue has not resolved, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional relevant patient information be provided, this complaint would be re-assessed.The complaint was confirmed, but the root cause could not be determined.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

Event Description

It was reported that during a hip labrum repair surgery, the drill bit broke in the bone, the doctor decided to leave the broken tip in the bone at that time.Week or so later the patient presented pain and had an mri and realized that the drill bit came out of the bone and was under the muscle in the hip.The patient has had all kinds of nerve issues due to the second surgery.An additional surgery was performed, and the drill was successfully removed by irrigation.Patient required medication, injections and therapy.Currently, the patient still has numbness but this condition is related to the original diagnose.

Manufacturer Narrative

Internal complaint reference: (b)(4).

• Brand Name: UNKNOWN DRILL PIN AND WIRE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10744573
• MDR Text Key: 213381218
• Report Number: 1219602-2020-01671
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/11/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 04/01/2021; 09/22/2021; 01/21/2022; 10/27/2022
• Supplement Dates FDA Received: 04/08/2021; 10/04/2021; 01/24/2022; 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 60 KG