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

Catalog Number	SD03.161.057
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(4).Device history records review was conducted.The report indicates that the: complaint condition: threaded portion snapped off.Mfg date: 09/15/2011 ¿ lot qty.(b)(4).These parts were manufactured by taking an existing product (03.661.125) and removing the silicone handle.Then a 6mm hex coupling was added to where the silicone handle was.Review of the device history record(s) showed that there were no issues during the manufacture of the 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 a patient underwent an anterior lumbar interbody fusion (alif) at l5-s1 on (b)(6) 2016.Upon insertion of a temporary fixation pin (tfp) and removal to reposition the antegra plate, the threaded portion of the tfp snapped off of the main shaft, in the s1 vertebral body on the left, due to repeated use and fatigue.The broken portion of the tfp was retrieved and verified by fluoroscopy.No surgical time delay nor patient harm reported.The patient status is unknown.This complaint involves one device.Concomitant device reported: unknown antegra plate (part # unknown, lot # unknown, and quantity unknown).This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device is not expected to be returned for manufacturer review/investigation.Updated information (b)(6) 2017, no patient harm reported therefore complaint downgraded from (si) to a reportable malfunction (rm).There were no patient harm or adverse event reported.Device 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
Updated verbiage (b)(6) 2017: this complaint was initially reported as serious injury (si) with a reportable malfunction (rm).The broken portion of the tfp was retrieved and verified by a routine fluoroscopy.This report is being amended from si/rm to rm only.
Additional Manufacturer Narrative
The initial complaint was reviewed and found to be a duplicate of another complaint (b)(4).All event details will be captured will be captured in that complaint and medwatch report mfr number 2530088-2016-10346.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 initial complaint was reviewed and found to be a duplicate of another complaint (b)(4).All event details will be captured will be captured in that complaint and medwatch report mfr number 2530088-2016-10346.

• Brand Name: TEMPORARY FIXATION PIN W/HXC
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6191662
• Report Number: 2530088-2016-10348
• Device Sequence Number: 13669360
• 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: Other
• Type of Report: Initial,Followup,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?: Yes
• 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?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 01/17/2017; 01/23/2017
• 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 ANTEGRA PLATE (PART # & LOT # UNK)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 86