MAUDE Adverse Event Report: SYNTHES SELZACH INSERTION HANDLE FOR SUPRAPATELLAR; NAIL, FIXATION, BONE

Catalog Number 03.010.440

Device Problem Sticking (1597)

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

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records has been requested.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 surgery, when inserting a suprapatellar tibial nail insertion, the driving cap broke off into the insertion handle.There were no fragments generated.There was no patient harm or surgical delay.Surgery was completed without incident.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Without a lot number the device history records review could not be completed.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

This is report 1 of 2 for (b)(4).

Manufacturer Narrative

It was noted that an incorrect part number (03.010.040) was provided for the device history record review, hence, the records could not be located.The correct part number (03.010.440) was provided and a review of the records was completed.Dhr 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

The returned instruments were examined and the complaint condition was able to be confirmed as the threaded tip of the driving cap was found to be broken off and retained by the insertion handle.No definitive root cause was able to be determined however the failure mode is consistent with excessive impaction while the driver cap was not fully inserted into the insertion handle.The returned suprapatellar insertion handle (03.010.440 lot 113171) was returned in good functioning condition.The fragment of the driving cap remains threaded into the proximal hole.As the handle functioned as intended and did not fail, no further investigation is necessary.The returned driving cap was received with the connecting screw sheared off.Thus the ¿broken: intraoperatively¿ portion of the complaint condition is confirmed but cannot be replicated as the instrument is already broken.The material at the fracture site appears to be homogenous.The top of the driving cap shows witness marks consistent with impaction some of which are not centered which may have provided an off-axis loading condition.The overall returned condition is consistent with the expected result of excessive hammering amplified by having the driving cap not fully inserted.The complaint condition, ¿broken: intraoperatively,¿ is a result of the method of use of the driving cap.The design, materials and finishing processes were found to be appropriate for the intended use of this device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: INSERTION HANDLE FOR SUPRAPATELLAR
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach PA CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5224984
• MDR Text Key: 31239604
• Report Number: 2520274-2015-17257
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111667
• 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,Followup
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.440
• Device Lot Number: 113171
• Other Device ID Number: (01)10886982068828(10)113171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/04/2015; 12/15/2015; 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2011
• 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