MAUDE Adverse Event Report: SYNTHES BRANDYWINE LOCKING BOLT MEASURING DEVICE; GAUGE,DEPTH

Catalog Number 357.402

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: part returned to manufacturer on mar 24, 2014.Device evaluation anticipated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: the locking bolt measuring device is intended to be used with the trochanteric fixation nail system and recommended to be used through the 11mm/8mm protection sleeve for determination of the correct locking bolt/screw length.Per as received condition of the device shows little signs of use and the reason the ball retainer fell apart cannot be precisely determined without the missing retaining ball however, if force was used to disassemble this delicate device for trial or cleaning, the ball retainer could become dislodged and lost.Although it is the function of the retainer ball of this device to apply light pressure to the graduated slide and if the ball feature was absent, the device would however still function for its intended measuring function.The usage of the device is best understood through its intended measuring function with each tf nail used as recommended.The force used to disassemble the device rather than a design deficiency resulted in dislodging of the ball.The complaint description is confirmed but determined to not have resulted from a defect in the device design.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 while a trochanteric fixation nail (tfn) system tray was being restocked, the depth gauge was noticed to be broken.The silver ball bearing on the inside shaft is missing causing the depth gauge to come apart.No case or patient involvement.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.The dhr was reviewed and mrr #(b)(4) was found on p/n 357.402.4 lot #4965565 for hook end bent on 1 part out of 27 supplier parts.The qe scrapped the 1 nonconforming part and returned it to the supplier.This nonconfomance is not relevant to the complaint because the issue is on the hook component that is not associated with the ball.No issues were found during manufacture that would contribute to the complaint condition.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
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3679725
• MDR Text Key: 11564333
• Report Number: 2530088-2014-10033
• Device Sequence Number: 1
• Product Code: HTJ
• 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,Followup,Followup
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.402
• Device Lot Number: 5094412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2005
• 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