MAUDE Adverse Event Report: SYNTHES OBERDORF BONE SPREADER 12MM BEAK WIDTH; INSTRUMENT COMPRESSION

Catalog Number 399.130

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Mfr date: unknown; greater than 15 years ago.Device history record not available as device is older than 15 years.Per procedures at the time the manufacturing documents for instruments had to be stored for 10 years.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 a lamina spreader/bone spreader was found broken; the inner spring mechanism was broken therefore the lamina spreader would not function.There was no patient involvement.There is no information available to how the instrument broke.No additional information available.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: it was reported that the bone spreader (399.130 lot 5037) was found to have a broken inner spring mechanism during sterile processing.There was no patient or surgical involvement.The returned instrument was examined and the complaint condition was able to be confirmed as the male leaf spring was found to be fractured; fragment not returned.No definitive root cause was able to be determined as details as to the method of use at the time of failure were not available; the failure mode is consistent with the application of excessive pressure.Per the technique guide, the bone spreader (399.130) is noted in three spine system technique guides: veptr, veptr ii and t-plif minimally invasive and auxiliary instruments.The device it utilized for chest wall distraction (veptr/veptr ii) or intervertebral disc space distraction (t-pal).The returned instrument was examined and the complaint condition was able to be confirmed as the male leaf spring was found to be fractured approximately 65mm from the inferior end (spring should be approximately 115mm long).No definitive root cause was able to be determined as details as to the method of use at the time of failure were not available; the failure mode is consistent with the application of excessive pressure.Relevant drawings for the returned instrument were reviewed: top-level and male leaf spring.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A device history review was unable performed as no device history records (dhrs) are available.At the time of manufacturing, all related documents for instruments were stored for 10 years.No definitive root cause was able to be determined as details as to the method of use at the time of failure were not available; the failure mode is consistent with the application of excessive pressure.During the investigation no product design issues or discrepancies were observed that may have contributed to the 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.

• Brand Name: BONE SPREADER 12MM BEAK WIDTH
• Type of Device: INSTRUMENT COMPRESSION
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5357093
• MDR Text Key: 35969791
• Report Number: 8030965-2016-10167
• Device Sequence Number: 1
• Product Code: HWN
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 399.130
• Device Lot Number: 5037
• Other Device ID Number: (01)07611819027565(10)5037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2016
• 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