MAUDE Adverse Event Report: SYNTHES GMBH QC F/K-WIRES 0.6-3.2 F/532.001 532.010; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.022

Device Problems Material Fragmentation (1261); Compatibility Problem (2960); Complete Loss of Power (4015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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.Additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).

Event Description

It was reported that the quick coupling device did not function.It was further reported that sterile processing discovered incarcerated wire fragments during a routine cleaning and maintenance.It was observed that there was debris in the cannula that could not be removed.It was not reported if the device was used in surgery, or if there was patient involvement.The reporter stated that they were not sure of the date or surgery in which the event occurred.The reporter further indicated that they were present in most procedures where small power was used and did not recall any issues during a procedure, and certainly nothing where a case was delayed, or a malfunction was observed.The reporter stated that the event occurred either during a procedure in which they were absent, or else it was not noticeable enough to observe during surgery, but enough for sterile processing to notice while cleaning the cannulated.The reporter further indicated that this event was the third different wire driver in the last month to retain metal, and each of the three wire drivers one time each.These were likely not from the same event.It was not reported if there were any delays in a surgical procedure or if a spare device was available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report 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.Quality engineering evaluated the device and observed that the device passed all manufacturing specifications.Therefore, the reported condition was not duplicated nor confirmed.An assignable root cause was not determined.

• Brand Name: QC F/K-WIRES 0.6-3.2 F/532.001 532.010
• 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: 11252198
• MDR Text Key: 229608464
• Report Number: 8030965-2021-00706
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819107199
• UDI-Public: 07611819107199
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1