MAUDE Adverse Event Report: SYNTHES HAGENDORF DEPTH GAUGE; GAUGE, DEPTH

Catalog Number 03.161.028

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: event date: unknown.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.Manufacturing location: (b)(4).Manufacturing date: 11june2013.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 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 after opening a package containing evaluation set the depth gauge, was noted to have a piece of metal that had sheared off the instrument.There was no patient involvement.No additional information was available.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; 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

A product investigation was completed: upon visual inspection of the complaint device, it can be seen the needle of the depth gauge has broken off from the handle of the depth gauge.The stem is press fitted than laser wielded on the measuring body.Laser wield marks can be seen the handle.A root cause could not be determined; a possible cause could be rough handling of the instrument lead to the stem breaking resulting in the complaint condition.The complaint is confirmed.Per the technique guide, the depth gauge is part of the synapse system and occipital cervical fusion system.The system is an enhanced set of instruments and implants for posterior stabilization of the upper spine.The system is interchangeable with the synapse system, axon pedicle screw system, cervifx implant system/starlock system and depuy synthes spine occipital cervical fusion system.The relevant drawings were reviewed.The design history was found to not 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 part was determined to be suitable for the intended use when employed and maintained as recommended.A root cause could not be determined; a possible cause could be rough handling of the instrument lead to the stem breaking resulting in the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.During the investigation no product design issues or discrepancies were observed that may have contributed to the 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: DEPTH GAUGE
• 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: 5188789
• MDR Text Key: 29871769
• Report Number: 3003875359-2015-10447
• 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: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.161.028
• Device Lot Number: 8297457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2013
• 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