MAUDE Adverse Event Report: SYNTHES BRANDYWINE SLIDE/FIXED HAMMER 700 GRAMS; HAMMER, SURGICAL

Catalog Number 03.010.056

Device Problems Break (1069); Material Disintegration (1177)

Patient Problem No Patient Involvement (2645)

Event Date 08/19/2016

Event Type  malfunction  

Manufacturer Narrative

No patient involvement.Device is an instrument and is not implanted/explanted.Device returned.Evaluation not yet completed.Manufacturing location: (b)(4).Manufacturing date: 21-apr-2005.Part #: 03.010.056, lot#: 4803822 (non-sterile) - slide/fixed hammer 700 grams.(b)(4) was created on 18-mar-2005 for nicks scratches is not relevant to complaint condition.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 returned.Evaluation not yet completed.Device 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 the slide fixed hammer broke in the wash.The handle disintegrated and broke in half down the middle.There was no patient involvement.No additional information is available.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: a slide/fixed hammer (03.010.056 lot 4803822) was found to be broken during sterile processing; the handle was ¿disintegrated and broke in half down the middle.¿ the returned instrument was examined and the complaint condition was able to be confirmed as the hammer¿s handle was received broken from the shaft; approximately half of the handle was returned.No definitive root cause was able to be determined however the device handle is composed of phenolic le grade which is susceptible to becoming brittle after repeated thermal cycle such as that which would occur during the sterilization cycle.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.The device is 11+ years old (mfg apr-2005), as such instrument age likely 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: SLIDE/FIXED HAMMER 700 GRAMS
• Type of Device: HAMMER, SURGICAL
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5926601
• MDR Text Key: 53903488
• Report Number: 2530088-2016-10237
• Device Sequence Number: 1
• Product Code: FZY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.056
• Device Lot Number: 4803822
• Other Device ID Number: (01)10886982067289(10)4803822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2005
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1