MAUDE Adverse Event Report: SYNTHES BRANDYWINE LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS; GAUGE, DEPTH

Catalog Number 357.402

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/04/2016

Event Type  Injury  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Part 357.402, lot 4693316: release to warehouse date: december 17, 2003.Made at: (b)(4).No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of this 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.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 during a trochanteric fixation procedure (tfn) of a femur on (b)(6) 2016, while measuring the distal locking screw the tip of the locking bolt measuring device broke off.The surgeon was unable to retrieve the broken fragment; therefore fragment remained in the patient.In addition, the screw of the helical blade inserter also sheared off during the procedure.The surgeon was not aware that the inserter was broken; it was noticed while being taken apart for cleaning in central processing department (cpd).There were no pieces of the inserter left in the patient.The surgery was successfully completed with same instruments without any surgical delay.The patient was reported as stable at the end of the procedure.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

A product development investigation was performed on the returned device (locking bolt measuring device f/trochanteric fixation nails, part # 35.402, lot # 4693316).The returned locking bolt measuring device (357.402) was confirmed to have a broken distal tip.The measuring hook is also bent, and the compression spring and ball were missing from the slider assembly.The device has surface wear which does not impact functionality.A visual inspection, drawing review, and device history record (dhr) review were performed as part of this investigation.The complaint is confirmed.Replication of the complaint condition is not applicable as the device is already broken.Use of the returned device is outlined in the titanium trochanteric fixation nail system - screw option technique guide.The following drawings were reviewed during investigation: locking bolt measuring device, slider assembly and hook.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.The diameter of the measuring hook tip was measured and found to be within the specification.No definitive root cause was able to be determined.The damage to the measuring device is likely related to excessive force during use and rough handling.There were no issues during the manufacture of this 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: LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS
• Type of Device: GAUGE, DEPTH
• 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: 6212738
• MDR Text Key: 63516710
• Report Number: 2530088-2016-10353
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982196255
• UDI-Public: (01)10886982196255(10)4693316
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.402
• Device Lot Number: 4693316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2003
• 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 Outcome(s): Required Intervention