MAUDE Adverse Event Report: SYNTHES SELZACH SCREWHOLDER F/90° SCREWDRIVER WITHOUT INSERT; DRILL, BONE, POWERED

Catalog Number 03.505.010

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 08/24/2015

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: event happened pre-surgery before there was patient involvement.Additional product code: dzj.Device is an instrument and is not implanted/explanted.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Manufacturing location: (b)(4).Supplier: diener ag.Manufacturing date: 28august2013.No non-conformance reports were generated during production.Review of the device history record(s) 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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was detected before the surgery that spring of the reported screw holder was missing.The staff found a loosened ball as well which lead to detecting the missing spring of the reported screw holder.No consequences to the planned surgery were reported because the event was pre-surgery.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: a product investigation was reported: the missing parts were not assembled.Visual inspection indicates an assembling error.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.The subject device was received.The investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SCREWHOLDER F/90° SCREWDRIVER WITHOUT INSERT
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach 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: 5056927
• MDR Text Key: 25040106
• Report Number: 3000270450-2015-10175
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Report Date: 08/25/2015

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: 03.505.010
• Device Lot Number: 8133365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2013
• 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