MAUDE Adverse Event Report: SYNTHES HAGENDORF SYNFRAME RING CLAMP; MISC ORTHO SURGICAL INSTR

Catalog Number 387.347

Device Problems Device Slipped (1584); Device Damaged by Another Device (2915)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that six (6) synframe ring clamps were running off and are not holding ring firmly.It was also reported that two blades were bending at the arm interface.It was reported that the surgeon mentioned in passing that some of the ring clamps were not holding the ring firmly and that some of the blades were bending.The sales consultant went through the set and pulled out the parts that were not functioning properly.There was no patient or case involvement.This complaint involves 8 devices.This is report 5 of 6 for (b)(4).

Manufacturer Narrative

Additional narrative: no patient involvement.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Dhr review ¿ manufacturing location: (b)(4).Manufacturing date: 17.Sep.2008.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.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 development investigation was performed for the subject device (part number 387.347, lot number 1973025, synframe ring clamp).The subject device was returned for the complaint condition of ¿the synframe ring clamp is running off and is not holding ring firmly.¿ upon receipt of the device, it was observed that the device could be tightened fully.The device shows signs of wear.There are markings and uneven wear on the outer edges where this device would attach to the ring, indicating that this was placed on the inner radius of the ring, instead of the outer radius where it is meant to snap onto.Based on this observation, it is possible that this device was being used incorrectly and as a result could not fully tighten onto the retractor.The drawings were reviewed for this part and were found to be adequate in design and materials for the intended use of this device.As previously reported, 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.This complaint could not be confirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SYNFRAME RING CLAMP
• Type of Device: MISC ORTHO SURGICAL INSTR
• 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: 4851125
• MDR Text Key: 5931435
• Report Number: 3003875359-2015-10295
• Device Sequence Number: 1
• Product Code: LXH
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2015

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: 387.347
• Device Lot Number: 1973025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2015
• Initial Date FDA Received: 06/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2008
• 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