MAUDE Adverse Event Report: SYNTHES GMBH K-WIRE ATTACHMENT FOR PEN DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.037

Device Problem Premature Separation (4045)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/23/2021

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Concomitant med products and therapy dates: k-wire device; (b)(6) 2021.Udi:(b)(4).

Event Description

It was reported that during an unspecified surgical procedure, it was observed that the kirshner wire (k-wire) attachment device did not adequately catch the 'needle' (wire) which caused the device to slip and was unable to be removed from the bone.According to the reporter, the k-wire was initially engaged and in the bone, however when trying to remove it, the k-wire attachment device disengaged and it was not possible to remove the wire.It was reported that this caused an 'affectation' in the patient.It was reported that the surgeon had to perform an additional incision to remove the k-wire.It was reported that the procedure was completed using a spare device.It was not reported if there were any delays in the surgical procedure.It was reported that no fragments were left in the patient and the patient was in good health.There was patient involvement.There were no reports of prolonged hospitalization due to the event.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device failed pre-repair assessment for general condition, check clamping range on tool coupling, check of free moving and function test.It was also determined that the device had three clamps that hold the k-wire that were won out and would not old the wire securely.It was also noted that the bearings and some of the worn parts were found to be not functioning properly and the worn -out internal parts and the external lever showed signs of wear.Device history record shows the lot of 05.001.037 product was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component wear.

• Brand Name: K-WIRE ATTACHMENT FOR PEN DRIVE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12184814
• MDR Text Key: 265372490
• Report Number: 8030965-2021-05601
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819167872
• UDI-Public: 07611819167872
• Combination Product (y/n): N
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.037
• Device Lot Number: L659220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/16/2021
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention