MAUDE Adverse Event Report: SYNTHES USA 1.1MM THREADED GUIDE WIRE 150MM

Catalog Number 292.622

Device Problem Residue After Decontamination (2325)

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

Event Type  malfunction  

Event Description

It was reported that the 3.0 mm ti cannulated screw instrument and implant set (p/n 145.17) was submerged in water after a storm, (b)(4).The sales consultant's car and the set were completely under water for a few hours, possibly longer; subsequently, the set was soaked.Sales consultant also mentioned that when he looked inside the set there was sand/sediment/mud and remembers some oxidation/rust on parts of the set (he couldn't be specific).The set was supposed to be set aside to be disposed of but was inadvertently missed.When returned to the synthes facility, the set was decontaminated and sent out to be used by a hospital.Reportedly, the first time it was shipped out, the set was not used and was sent back unused.The set was then decontaminated again when it was returned and eventually sent out to a hospital where it was used.The set was returned and used 4 times total after being involved in the hurricane.Per an order report from (b)(4) 2013, fourteen devices (parts 292.622, 314.465, 402.620, 402.624, 292.623, 402.618, 402.632 and 402.732) were billed for usage and used on a patient.This report is 5 of 14 for (b)(4).

Manufacturer Narrative

This device was used for treatment, not diagnosis.Date of event unknown.The following parts are also included in the set.Synthes cannot identify whether or not they were used during the procedure with the patient: 304.49 exempt fsm, 309.501 exempt hxx, 310.221 k962913 hwe, hsz,gfa,gff, 310.804 exempt hww, 311.43 exempt hwx, 312.151 exempt fzx, 312.153 exempt fzx, 313.969 exempt hxx, 314.463 exempt hxx, 314.464 exempt hxx, 319.291 exempt lxh, 319.292 exempt lxh, 319.702 exempt htj, 319.97 exempt htd, 398.408 exempt hte, 398.409 exempt hte, 402.608-402.640 k962823 hwc, 402.714-402.740 k962823 hwc, 419.89 k962823 htn, 419.972 pre-amendment htn.Device is an instrument and is not implanted / explanted.Device was received for evaluation (date unspecified).Investigation is on-going.Subject device has been received and is currently in the evaluation process.No conclusion can be drawn.Review of manufacturing records has been requested.Residual testing was performed on the set.The results showed on (b)(6) 2014 that the implants are cytotoxic and furthermore some non-volatile materials (yet to be identified) also are being identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.1MM THREADED GUIDE WIRE 150MM
• Type of Device: GUIDE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3870815
• MDR Text Key: 4508188
• Report Number: 2520274-2014-11823
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.622
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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