MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 7.0 COMPRESSION SCREW DRILL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71674070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a trauma surgery, the tip of the 7.0 compression screw drill broke off and pieces fell inside the patient's wound, the broken piece was retrieved but it is unknown how.The procedure was resumed, after a non-significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference:(b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during a trauma surgery, the tip of the 7.0 compression screw drill broke off and pieces fell inside the patient's wound.It is unclear if the piece was retrieved.The procedure was resumed, after a non-significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.Surgical reports and operative notes are not available.
Additional Manufacturer Narrative
H2: additional information ¿h6: health effect - impact code.¿ h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the tip of the device broke off.The broken piece was returned.The device shows signs of significant wear and use.This inspection was conducted by naked eye.The clinical/medical investigation concluded that as of the date of this investigation, no additional supporting documentation has been received or made available for review.Therefore, a thorough medical investigation could not be rendered, nor could the definitive clinical root cause of the reported adverse event be determined.Per the report, the drill tip broke off and pieces fell down in a female patient during a trauma surgery.According to the report, the retrieval of the broken piece was confirmed, however, the method of retrieval is unknown.The report stated that the procedure was resumed with a smith an nephew back-up device after a non-significant delay without patient injury.Based on the limited information provided, unable to definitively rule out a user technique/procedural variance as a contributing factor to the reported event.The impact to the patient was the non-significant surgical delay.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any 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 potential factors that could contribute to 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.Should 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.

• Brand Name: 7.0 COMPRESSION SCREW DRILL
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20328119
• Report Number: 1020279-2024-01952
• Device Sequence Number: 15455080
• Product Code: HSB
• UDI-Device Identifier: 03596010560636
• UDI-Public: 3596010560636
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2024

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 Catalogue Number: 71674070
• Device Lot Number: 20LNG0047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/01/2024; 10/17/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/02/2024; 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female