MAUDE Adverse Event Report: SYNTHES USA SYNFRAME HALF RING; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number 387.337

Device Problems Component Missing (2306); Material Distortion (2977)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It has been reported part 357.372, lot 6045128 (helical blade inserter) the alignment indicator is stuck and can't be unscrewed.Part 357.372, lot 6270763 (helical blade inserter) the alignment indicator will not tighten down onto the top of the main body of the instrument.Part 387.337 x2 (synframe half ring) screws are missing.All items discovered preoperatively and were traded out with new instruments to complete the sets.No case or patient involvement.This report is 3 of 4 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.A service history maintenance review was performed.The investigation of the complaint articles indicates that the: service history review: lot #1541106, no service history review can be performed as this is a lot controlled item.The manufacture date of this item is unknown and cannot be traced.Ncr (b)(4) refers to the ¿etch¿ on the device, does not match the work order or the label.This ncr is unrelated to the reported issue.The service history evaluation is unconfirmed.The customer reported the screws were missing.A service history maintenance review was performed.The investigation of the complaint articles indicates that the: the repair technician reported missing parts as the reason for repair.The cause of the issue is unknown.The following parts were replaced: hex screw m7 x 0.75, stop screw.This item was repaired, passed synthes final inspection and returned to the customer on (b)(4) 2015.The evaluation was confirmed 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: two parts belonging to the trochanteric fixation nail system was returned; both are helical blade inserters (part 357.372, lot 6045128, manufactured december 17, 2008 and lot 6270763, manufactured december 03, 2009).Upon receipt of these devices it was seen that both lot 6270763 and lot 6045128 are in average condition, with minor signs of hammering, the alignment indicator can be attached and removed and can be tightened onto the shaft of the inserter, there is minor damage to the internal pin of the alignment indicator but it can be mated with the shaft.The complaint against both of these parts is unconfirmed.The root cause is undetermined.Two synframe half rings (part 387.337 lot 1541106) were returned with the complaint that screws are missing.Per service and repair the complaint was confirmed.The following parts were replaced for both synframe half rings: hex screw m7 x 0.75, stop screw.This item was repaired, passed synthes final inspection and returned to the customer.The evaluation was confirmed.The drawings for the helical blade inserter were reviewed.The device conforms dimensionally to the drawings, and the design was determined to be adequate for the intended use of this device.The complaints against these helical blade inserters are unconfirmed and the root cause is undetermined.The design of this device was found to be adequate for its intended use and did not contribute to this complaint condition.The complaint against the synframe half rings was confirmed, the screws were replaced and the devices were returned to the customer.The design of this device was found to be adequate for its intended use and did not contribute to this complaint condition.Corrected service history review: lot 1541106: no service history review can be performed as this is a lot controlled item.The manufacture date of this item is unknown and cannot be traced.There was a non-conformance report referring to the etch on the device does not match the work order or the label.This non-conformance report is unrelated to the reported issue.The service history evaluation is unconfirmed.Corrected service and repair evaluation: the customer reported the screws were missing.The repair technician reported missing parts as the reason for repair.The cause of the issue is unknown.The following parts were replaced: hex screw m7 x 0.75, stop screw.This item was repaired, passed synthes final inspection and returned to the customer.The evaluation was confirmed.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: SYNFRAME HALF RING
• Type of Device: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4773068
• MDR Text Key: 5951617
• Report Number: 2520274-2015-13833
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2015

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: 387.337
• Device Lot Number: 1541106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 05/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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