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  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows it was reported that the depth gauge for locking screws was found to be defective during instrument inspection.The retaining ball and spring are missing.This item is from an evaluation loaner set.No further information was provided.No reported patient or procedure harm noted.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional product code: fsm.Device is an instrument and is not implanted/explanted.Device history records was conducted.The report indicates that: no anomalies were detected during device history record review.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Should state: "complaint report received from (b)(4)".If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Complaint report received from (b)(4).

Manufacturer Narrative

A pd evaluation was conducted.The report indicates that the returned device shows significant use during its 4.75 year lifespan.The distal hooked tip of the device is slightly bent and the ball bearing is missing.Due to little information surrounding the events that led to the complaint condition, and exact cause for the complaint condition cannot be determined.Damage could have been caused during sterile processing, when in a disassembled state.A visual inspection, dimensional inspection, risk assessment review, drawing review, and dhr review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed, but not the result of a design issue.(b)(4) for the device(s) 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.The returned instrument(s) are additional instruments used during femoral and tibial nail implantations and proper use and maintenance are addressed in technique guides j5296-c, j8377-b, j10459-c.The returned device is multi use and is used for determining the length for locking screw selection.The complaint condition was most likely due to rough handling in sterile processing and wear/tear over the life of the instrument, rather than the design of the instrument.This complaint condition is possibly a result rough handling during sterile processing, and not the device's design.Because of this, the complaint is determined not to be a design deficiency.The returned part(s) are determined to be suitable for their intended use when used and maintained as recommended.This complaint is confirmed, but the design of the device did not contribute to this complaint.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 FOR LOCKING SCREWS TO 100MM FOR IM NAILS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4303770
• MDR Text Key: 5059413
• Report Number: 3003875359-2014-10410
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• 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: 3368784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2010
• 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