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

Catalog Number 03.010.072

Device Problems Bent (1059); Incorrect Measurement (1383)

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

Event Date 01/29/2016

Event Type  malfunction  

Manufacturer Narrative

Additional product code: fsm.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received the investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review - manufacturing site: (b)(4).Manufacturing date: 19 sep.2007.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.

Event Description

It was reported that during a tibial shaft fracture surgery on (b)(6) 2016 surgeon commented twice the depth gauge for locking screws to 100mm for im nails did not measure accurately.Surgeon switched out a screw for a screw of more accurate length.Delay in surgery of ten (10) minutes.Patient is in good health.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: 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.

Manufacturer Narrative

Product investigation summary: the following device(s) were received: depth gauge for locking screws (part 03.010.072 | lot 1734175) the device was returned with minimal cosmetic damage that is consistent with their 8+ years of use.The distal hooked tip of the device is bent and wavy.This damage is likely the cause of the inaccurate measurement that the surgeon experienced.The damage does not appear to be the result of normal use.Rather, it appears to be the result of damage during cleaning/sterilization when in a disassembled state.However, the exact cause of the deformation could not be determined.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.The returned depth gauge is an additional instrument used during femoral, tibial, and humeral nail implantations for determining the length of locking screw.Its proper use and maintenance are addressed in technique guides.The relevant drawing 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.A review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No manufacturing or design issues were noted during the investigation.The design is determined to be adequate for its intended use when used and maintained as recommended.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: 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: 5444885
• MDR Text Key: 38480417
• Report Number: 3003875359-2016-10117
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• 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: 1734175
• Other Device ID Number: (01)10886982067449(10)1734175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2007
• 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: 27 YR