MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS MINI Q-COUPL F/532.001 532.010 532.101 5; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.011

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the mini q-coupling device became disassembled.There were no delays to the surgical procedure.It was not reported if a spare device was available for use.There was patient involvement reported.It was not reported if there were any 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

Udi: (b)(4).The manufacturer location was documented as unknown in the initial report.The location has been updated to (b)(4).Contact office name/address has been updated accordingly to reflect the corrected manufacturing facility.Device manufacture date: the device manufacture date was documented as unknown in the initial report.The device manufacture date has been updated as apr 11, 2014.Device evaluation: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.It was observed that the device was returned in a dismantled state.It appeared that all of the received parts were cleaned before arriving at the investigation site.Therefore, the investigation could not be performed.It was determined that sufficient adhesives were applied on the threads to secure the parts and so they could not be identified.It was further determined that the compression spring was missing and not obtained.It was further determined that the device failed pretest for check the tool quick coupling, check for untrue running and marking and labeling.The assignable root cause was not determined.If additional information should become available; a supplemental medwatch report will be submitted accordingly.

• Brand Name: MINI Q-COUPL F/532.001 532.010 532.101 5
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6560513
• MDR Text Key: 74950769
• Report Number: 8030965-2017-12282
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 532.011
• Device Lot Number: MA12224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2017
• Initial Date FDA Received: 05/11/2017
• Supplement Dates Manufacturer Received: 08/23/2017
• Supplement Dates FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1