MAUDE Adverse Event Report: SYNTHES MONUMENT TEMPORARY FIXATION PIN-LONG; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number	03.661.125
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	05/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient age & weight not provided for reporting.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(4).A device history record (dhr) review was performed: dhr review for part #03.661.125, synthes lot#7258900.Release to warehouse date: 08-may-2013.Expiration date: n/a.Supplier: (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition 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
It was reported that during an l5-s1 alif (anterior lumbar interbody fusion) procedure, using the antegra system, the long temporary fixation pin broke off in the bone.The surgeon was removing the temporary fixation pin from the 4th and final hole of the 4-hole antegra plate in preparation of placing the last screw when the pin broke.The distal portion of the pin remains embedded.The proximal portion of the pin will be returned.The surgeon completed the procedure without placing a 4th screw.There was no reported surgical delay, and the patient was reportedly stable.There is one device on this complaint.There is 1 device in this complaint concomitant part reported: antegra 4-hole plate (quantity 1).This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
The device was received and the product evaluation is in progress.No conclusion can be drawn.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.
Event or Problem Description
The procedure was completed successfully.Patient outcome was reported as stable.
Additional Manufacturer Narrative
Therapy date.A product development investigation was performed.The following complaint device(s) was received by customer quality (cq): one temporary fixation pin-long (part number: 03.661.125, lot number: 7258900, mfg date: 08may2013).A visual inspection, drawing review and device history review were performed as part of this investigation.This complaint is confirmed.The temporary fixation pin is part of the antegra system and allows the user to lag the plate to the bone.Information regarding use of the system is provided per the antegra instruments and implants technique guide.The device was received with a roughly transverse fracture at the distal tip.The break is in the threaded region approximately 18.53mm from the start of the 3.8mm diameter portion of the device.The broken portion was received.The fracture site was examined under 10x lupe and no material voids or irregularities were identified.The balance of the device shows wear consistent with significant use and is in functional condition.Thus, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the device is already broken.Relevant top level drawings for the device(s) were reviewed.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.The received condition of the temporary pin is consistent with failure due to torsional forces beyond the yield strength of the shaft.However, given the unknown specifics at the time of the break and over the lifetime of the device, a root cause could not be definitively determined.During the investigation, no product design issues or discrepancies were observed that may have contributed to the 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: TEMPORARY FIXATION PIN-LONG
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6594432
• Report Number: 1719045-2017-10508
• Device Sequence Number: 16199657
• Product Code: LXH
• UDI-Device Identifier: 10705034721217
• UDI-Public: (01)10705034721217(10)7258900
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.661.125
• Device Lot Number: 7258900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 06/19/2017; 06/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR