MAUDE Adverse Event Report: SYNTHES USA 2.0MM THREADED GUIDE WIRE 230MM; WIRE, SURGICAL

Catalog Number 292.65

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

Patient Problems Sedation (2368); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 09/22/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient's initials, dob and weight not provided by reporter.Additional product code: jdw.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 a the tip of a threaded guidewire broke during a hip surgery performed on (b)(6) 2015.The surgery was stopped for one hour and a second surgeon was called upon to assist with the location and removal of the fragment.The guide wire tip was found inside the articulation of the patient's hip.An additional incision was made and the fragment was successfully removed by the assisting surgeon.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

The part was shipped directly to the complaint handling unit (chu) and received on october 8, 2015.Per standard procedure, the part was forwarded to monument for sterilization and returned to the chu on october 16, 2015 for evaluation.Product investigation summary: one 2.0mm threaded guide wire, 230mm, spade point, black (part 292.65 / lot number unknown) was received.The complaint condition is confirmed as the returned guide wire was received with a portion of the distal threaded tip missing.As the specific circumstances at the time of the break are unknown, a root cause could not be definitively determined.However, the break is consistent with a tensile break from excessive force.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.The evaluation shows that this guide wire is used across various procedures such as pediatric hip and condylar plates, 7.0mm cannulated screws, and angled blade procedures.This wire is designed to interface with other instruments and implants.As the reported procedure was a hip surgery and the patient reported to be 11 at the time of the procedure, the pediatric locking compression plate (lcp) system technique guide was reviewed.The returned guide wire was received with a portion of the distal threaded tip missing.The returned device is approximately 224.9mm long.Thus, based on the current design drawing, the missing fragment is estimated to be 5.1 +/-0.5mm.The fracture site was examined and no material voids or irregularities were identified.The remaining distal threads show wear and flattening and there are noted areas of scrapping around the shaft of the guide wire.The balance of the device is in working 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.As the lot number is unknown, the manufacture revision is unknown.A review of the current design drawing was performed.Multiple locations along the shaft were measured and the diameters, outside the noted damage, were found to be conforming to the specification of 2.0mm +0/-0.1 measuring a high of 1.982mm and a low of 1.970mm.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.The bending and tensile strength assessment rationale-wires was reviewed and addresses the tensile strength characteristics of a 2.0 mm diameter wire made of 316leh.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.As the specific circumstances at the time of the break are unknown, a root cause could to be definitively determined.However, the break is consistent with a tensile break from excessive force.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint.Implant and explant dates: device is an instrument and is not implanted or explanted.(b)(4).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.

• Brand Name: 2.0MM THREADED GUIDE WIRE 230MM
• Type of Device: WIRE, SURGICAL
• 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: 5145516
• MDR Text Key: 28073266
• Report Number: 2520274-2015-16416
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• PMA/PMN Number: PPREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR