MAUDE Adverse Event Report: SYNTHES BRANDYWINE DRILL/TAP AND SCREW GUIDE WITH POST-SHORT

Catalog Number SD312.025

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.(b)(6).Device is an instrument and is not implanted/explanted.A review of the device history records has been completed.(b)(4); manufacturing date: july 12, 2011 ¿ lot qty.5.Mrr 4320 was generated during fff (form, fit & function).Review of the device history record(s) showed that during the function check at fff, the devices were still too long.The design was revised to shorten the device.One hundred % of the lot was reworked and passed re-inspection and fff.The end where the oal (over-all-length) was shortened is on the opposite end of where the complaint condition is.Therefore this mrr #4320 is not relevant to the complaint condition.A review of the ¿make from¿ part dhr (03.613.001 / 3712849) that was issued from stock (bp20) to make this part (sd312.025 / 6638487) could not be conducted.No record found for this lot in docusphere.The dhr for this part will need to be conducted from the mfg location in (b)(4).Part 03.613.001 / 3712849.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.Manufacturing location: (b)(4), manufacturing date: 25.Mar.2011.No ncrs were generated during production.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 the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system 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 that during the initial anterior cervical fusion surgery performed on (b)(6) 2016 for c5-6 & c6-7 levels to treat cervical stenosis the custom drill/tap and screw (dts) guide with post short broke off.The guide has a small post on its tip and it goes in the plate hole to align the plate for screw insertion.After screw insertion when surgeon was pulling out the guide from the plate, 1mm tiny little post of the guide broke off.The broken piece was easily retrieved.No fragments remained in the patient was confirmed through the routine x-rays taken during the procedure.Surgeon used the long drill guide to complete the procedure.There was about 1 minute surgical delay due to reported event.Surgery was completed successfully with no patient harm, no additional medical intervention.Patient outcome post-surgery reported as stable.Concomitant device reported as: titanium anterior cervical compression plate (part # 450.536, lot # unknown, quantity 1), unknown screw (part # unknown, lot # unknown, quantity unknown).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the drill tap and screw guide (part number sd312.025, lot number 6638487).The subject device was returned with the complaint condition stating the position pin was found to broken from the guide body at the laser weld; position pin was returned.The complaint was confirmed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, drawing review and device history review were performed as part of this investigation.No product design issues or discrepancies were observed.The pin is intended as an alignment aid; as such minimal loading should be applied if the instrument is being utilized as intended.When used to insert a fixed-angle screw, the position pin should be inserted in a small post hole on the plate.When inserting a variable-angle screw, the plates diamond window should be utilized, which allows the position pin to move freely and accommodate a variety of screw angles without bending.Relevant drawings for the returned device were reviewed the design, materials and finishing processes were found to be appropriate for the intended use of this device.A device history review was performed for the returned instrument's lot number and no non-conformance records (ncrs) or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Mrr 4320 was generated for the overall device length exceeding specification; 100% of the lot was reworked and shortened, from the proximal end, to meet specification.This is not related to the complaint condition of broken position pin.No definitive root cause was able to be determined however the failure mode is typically related to the application of excessive loading on the position pin.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRILL/TAP AND SCREW GUIDE WITH POST-SHORT
• Type of Device: GUIDE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6166001
• MDR Text Key: 62381567
• Report Number: 2530088-2016-10343
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 10705034705804
• UDI-Public: (01)10705034705804(10)6638487
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD312.025
• Device Lot Number: 6638487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: COMPRESSION PLATE(PART # 450.536, LOT # UNK, QTY1; SCREW (PART/LOT# UNKNOWN, QUANTITY UNK)
• Patient Age: 34 YR
• Patient Weight: 104