MAUDE Adverse Event Report: SYNTHES BRANDYWINE TEMPORARY FIXATION PIN W/HXC; MISC ORTHO SURGICAL INSTR

Catalog Number	SD03.161.057
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional patient information: patient height reported as 5 feet and 8 inches.Additional patient identifier: (b)(6).Device is an instrument and is not implanted/explanted.Complainant device is expected to be returned for manufacturer review/investigation, but has yet to be received.A device history record review was completed for part sd03.161.057, lot # 6650183: release to warehouse date: on (b)(6) 2011, manufacturer: synthes brandywine.Relevance to complaint condition cannot be determined until the product is returned for investigation.Review of the device history record(s) showed that there were issues during the manufacture of the product that may contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
It was reported that during an alif (anterior lumbar interbody fusion) procedure at l5-s1 for spondy on (b)(6) 2016, the temporary fixation pin broke.The surgeon noted that placement of the antegra plate was not straight and the temporary fixation pin was backed in order to properly align the plate.While backing out the temporary fixation pin, the threaded portion of the pin broke off from the main shaft.The temporary fixation pin broke into two pieces and both pieces were easily retrieved.There was no surgical delay.Routine intraoperative fluoroscopic images were taken as standard for the procedure and not considered as additional intervention.The images verified that broken pieces were retrieved.The surgeon was satisfied with the stability of the construct.The procedure was completed successfully.The patient¿s postoperative status was reported as stable.Concomitant device reported: antegra plate (part # unknown, lot # unknown, quantity of 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A product development investigation was performed on the returned device (temporary fixation pin w/hex connector, part # sd03.161.057, lot # 6650183).The returned temporary fixation pin w/hex connector (sd03.161.057, 6650183) is used to temporarily fixate plates prior to screw insertion during antegra procedures for anterior fixation to achieve fusion in the lumbosacral spine.Unlike the standard temporary fixation pin (03.161.057), the temporary fixation pin w/hex connector has some special features including having a longer shaft and a hex connector.The returned pin was received with its threaded tip broken, which confirmed its complaint condition.As part of this investigation a visual inspection, drawing review, and root cause analysis were performed.The returned temporary fixation pin w/hex connector (sd03.161.057, 6650183) was manufactured on 15-sep-11 and drawing was reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.No material review reports (mrrs), non-conformance reports (ncrs), or actions related to the complaint condition were generated during production of the returned part(s).Review of device history record(s) showed that there were no issues during the manufacture of the product(s) which would contribute to the complaint condition.During the investigation no unidentified product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the available details it is not possible to determine a definitive root cause for the complaint condition, however it most likely occurred due to having been exposed to unintended off axis forces.The complaint description stated that the pin breakage occurred during an attempt to back it out, since the surgeon realized that the plate was misaligned.It is possible that it was attempted to reposition the plate while the pin was still inserted in bone or that attempting to manipulate the pin caused it to eventually break.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
Temporary fixation pin reportedly broke due to repeated use and fatigue.

• Brand Name: TEMPORARY FIXATION PIN W/HXC
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6185199
• Report Number: 2530088-2016-10346
• Device Sequence Number: 1069847
• Product Code: LXH
• UDI-Device Identifier: 10705034700847
• UDI-Public: (01)10705034700847(10)6650183
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2016

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: SD03.161.057
• Device Lot Number: 6650183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 01/26/2017
• 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: ONE (1) UNKNOWN ANTEGRA PLATE
• Patient Age: 65 YR
• Patient Weight: 86