MAUDE Adverse Event Report: SYNTHES MONUMENT HOLDING SLEEVE-STANDARD FOR MATRIX; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number	03.632.001
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.(b)(6).The subject device has been received and is currently undergoing investigation.A device history record review was performed for the reported subject device lot.Manufacturing location: synthes (b)(4), date of manufacture: nov 16, 2011.The review showed that there were no issues during the manufacture of the product lot that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Synthes europe reported an event in (b)(6) as follows: it was reported that during surgery to treat an l1 diffuse idiopathic skeletal hyperostosis (dish) trauma levels t10-l4 on (b)(6) 2017, the surgeon could not hold the screw straight on the retaining sleeve standard for matrix 5.5mm.He also found that the other screws came off this sleeve several times during insertion at the pedicle.The attending nurse also tried to mount screws to this sleeve but failed as well.The surgery was delayed by five (5) minutes due to the reported issue.Concomitant devices: screws (part# unknown / lot# unknown / quantity unknown).This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.A visual inspection, drawing review and dhr review were performed as part of this investigation.The returned device was found to have a broken thread.The most distal thread on the device was found to be broken and missing a fragment.The device condition would be likely to contribute to the reported complaint condition.The device shows normal surface wear based on the age of the device.The complaint is confirmed.Replication of the complaint condition is not applicable as the device is already broken.Relevant drawings were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.No definitive root cause was able to be determined.The failure is likely related to excessive force during use.There were no issues during the manufacture of this product that would contribute to this complaint condition.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.

• Brand Name: HOLDING SLEEVE-STANDARD FOR MATRIX
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6459723
• Report Number: 1719045-2017-10283
• Device Sequence Number: 10881720
• Product Code: LXH
• UDI-Device Identifier: 07611819378056
• UDI-Public: (01)07611819378056(10)6705459
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.632.001
• Device Lot Number: 6705459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS, QUANTITY UNKNOWN