MAUDE Adverse Event Report: SYNTHES SELZACH SAW ROUND 38.9*Ø5 Ø0.6 F/PIEZOELECTRIC S; DRILL, BONE, POWERED

Catalog Number 03.000.424S

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information is unknown.Additional product codes: erl, hbe, hwe.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.Manufacturing date: january 18, 2016.Manufacturing location: (b)(4) (device manufactured by subcontractor satelec, received and released for distribution in (b)(4).) business group: power tools.Device 03.000.424s is a batch number controlled product, therefore, no service history record review is possible.No non-conformance reports, rework or other relevant quality notifications were referenced in the device history record.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.The conclusion of the dhr review is that the final product, met inspection requirements, certification test values, and acceptance criteria.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 reported the sawblades broke during surgery.All fractured parts were successfully removed from within the patient.There was no report of patient harm or delay to the procedure.This is report 3 of 4 for (b)(4).

Manufacturer Narrative

The initial complaint was reviewed and to be a duplicate of (b)(4).The information has already been reported on medwatch mfr number 3000270450-2016-10095.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

The initial complaint was reviewed and to be a duplicate of (b)(4).The information has already been reported on medwatch mfr number 3000270450-2016-10095.

• 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: 5539133
• MDR Text Key: 41615170
• Report Number: 3000270450-2016-10081
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.000.424S
• Device Lot Number: 0864688
• Other Device ID Number: (01)07611819498426(10)0864688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2016
• 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