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

Catalog Number 03.010.440

Device Problem Mechanical Jam (2983)

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

Event Date 07/11/2015

Event Type  malfunction  

Event Description

It was reported that there was a problem taking an aiming jig off of an insertion handle at the end of an im nailing of a tibia.The hole in the insertion handle appeared to not be perfectly round.There was an approximate 3-5 minute surgical delay.The procedure was successfully completed.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: a product investigation was completed: the complaint condition is confirmed as the distal hole that mates with the aiming arm is significantly deformed such that an aiming arm would not properly attach in the returned condition.The insertion handle shows clear signs of hammering and use to drive the nail in the direction of removal.It is likely that the method of use and/or handling resulted in the condition; however, since the specific circumstances at the time of the damage are unknown the root cause cannot be definitively determined.The returned part was determined to be suitable for the intended use when employed and maintained as recommended and the risk assessment was found to adequately address the complaint condition.A device history record review was performed for the returned insertion handle.It was found that the device was manufactured in september 2011.No non-conformance reports 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.Per the technique guide, this device is used for insertion of the titanium cannulated tibial ¿ex nails when a suprapatellar approach is desired.The returned device was received intact and showing wear.There are nicks on the underside of the arch and significant deformation to the distal edge of the portion when the aiming are would attached.Both of these regions are not intended to withstand hammering.The diameter specification was tested with gauge pins for the two alignment holes.It was found that the proximal hole is within specification but the distal hole is deformed such that it is no longer within the specification.Thus, the complaint condition is confirmed, consistent with the report condition, and can be replicated as an aiming arm would not properly attach with the distal hole in the returned condition.The balance of the device shows surface wear and is in working condition.A review of the current design drawing was performed.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.The received condition is consistent with the result from excessive force from impact such as hammering.Per technique guide, light, controlled hammer blows can be used on the driving cap when needed to seat the nail and the insertion handle is not used during nail removal.The insertion handle shows clear signs of hammering and use to drive the nail in the direction of removal.It is likely that the method of use and/or handling resulted in the condition; however, since the specific circumstances at the time of the damage are unknown the root cause cannot be definitively determined.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

Device was used for treatment, not diagnosis.Additional narrative: lot number was identified upon receipt of subject device.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The subject device has been received and is currently in the evaluation process.Manufacturing facility was identified during device history record review.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: 4935846
• MDR Text Key: 17201688
• Report Number: 2520274-2015-14995
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2015

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: 11-3169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2015
• Initial Date FDA Received: 07/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2011
• 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
• Patient Age: 54 YR
• Patient Weight: 94