MAUDE Adverse Event Report: SYNTHES HAGENDORF INSERTER FOR TI ELASTIC NAILS; MISC ORTHO SURGICAL INSTR

Catalog Number 359.219

Device Problem Separation Failure (2547)

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

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

Additional patient identifier reported as:(b)(6).Patient weight reported as (b)(6).Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed on part # 359.219 / lot # 9417155: manufacturing site: (b)(4).Manufacturing date: 21/may/2015: no non conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 Description

It was reported that the inserter for titanium (ti) elastic nails would not release the elastic nail.Patient presented with both bone forearm fracture and was taken to surgery on (b)(4) 2017.The operative plan was to implant an elastic nail into each bone (radius and ulna).A 2.5mm ti elastic nail was chosen for each of the fractured bones.The surgeon chose to implant a nail in the ulna first, starting with a proximal entry site.When the nail was almost completely implanted, the surgeon attempted to loosen the inserter from the nail, at which time the inserter would not release the nail as it should have.The surgeon attempted to use the spanner wrench in the set but was unsuccessful in this attempt to loosen the inserter as well.The surgeon decided that the nail was in the appropriate position within the intramedullary canal and decided to cut the nail, and therefore the inserter, just below the tip of the inserter.Once the nail and attached inserter were cut, the rest of the case went according to plan.The second inserter in the set was used to insert the nail in the radius.The patient received the treatment that the surgeon planned on providing.A three (3) minutes surgical delay was noted.Procedure was successfully completed without requiring other medical intervention.The inserter is still grasping a piece of the 2.5mm ti elastic nail.Concomitant device reported: spanner wrench (part # unknown, lot unknown, quantity 1) elastic nail (part # 475.925, lot # unknown, quantity 1) this report is for one (1) inserter for ti elastic nails this is report 1 of 1 for complaint com-(b)(4).

Manufacturer Narrative

The following complaint device(s) was received by customer quality (cq): one inserter for ti elastic nails (part number: 359.219, lot number: 9417155, mfg date: 12sep2015).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.This complaint is confirmed.Please note the following concomitant device was also received one 2.5 mm ti elastic nail 440 mm (part number: 475.925, lot number: h206627, mfg date: 12oct2016); as per the complaint description the nail did not contribute to the complaint as the surgeon could insert the nail and cut the nail at the appropriate length.Therefore, no further investigation is required at this time.The 359.219 inserter for titanium elastic nails is an instrument routinely used in the titanium elastic nail system.The returned instrument(s) was examined and the complaint condition could be confirmed as the nail could not release from the inserter, the tip of the inserter could not be loosened and the two pins at the blue handle are sheared off and fell off once the device was loosened.The blue handle also shows visible hammer blows.Replication of the complaint condition is not applicable as the device will not release the implant and the handle is already broken.Top level assembly for the device was reviewed.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.Dhr review request part # 359.219 / lot # 9417155, manufacturing site: (b)(4), manufacturing date: 21.May 2015.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

• Brand Name: INSERTER FOR TI ELASTIC NAILS
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6590410
• MDR Text Key: 76054212
• Report Number: 3003875359-2017-10253
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982197214
• UDI-Public: (01)10886982197214(10)9417155
• 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: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 359.219
• Device Lot Number: 9417155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2015
• 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
• Patient Age: 10 YR
• Patient Weight: 43