MAUDE Adverse Event Report: SYNTHES HAGENDORF DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS; GAUGE, DEPTH

Catalog Number 03.010.072

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional product codes for this report include fsm.Device is an instrument and is not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing location: (b)(4) - manufacturing date: july 27, 2006.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

Event Description

It was reported that a depth gauge for locking screws was missing the ball bearing.The ball bearing prevents the calibrated part of the device from falling out.Without the piece, the device will not stay together properly.The piece likely fell off during the cleaning process and was discovered upon inspection.No reported patient or procedural involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product development investigation was performed for the subject device (depth gauge for locking screws, part number 03.010.072, lot 1528053).The returned device is in excellent condition and appears undamaged.The body and slider of the device have very minor scratches consistent with routine use.The distal hooked tip of the device is bent and wavy.Additionally, the ball bearing on the side of the internal slider is missing and was not returned.The deformation appears to be the result of damage during cleaning/sterilization when in a disassembled state, but it is unknown what caused the ball bearing to be lost.A visual inspection, functional test, and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS
• Type of Device: GAUGE, DEPTH
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5294958
• MDR Text Key: 33437570
• Report Number: 3003875359-2015-10542
• 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
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.072
• Device Lot Number: 1528053
• Other Device ID Number: (01)10886982067449(10)1528053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2006
• 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