MAUDE Adverse Event Report: UMKIRCH HAMMER 700 GRAMS; HAMMER, SURGICAL

Catalog Number 399.430

Device Problems Dent in Material (2526); Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 04/13/2015

Event Type  malfunction  

Event Description

Report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during the surgery a fracture of the hammer has loosened and hit the surgeon at the lip.There was a surgical delay of 4 minutes.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information not reported.Device is an instrument and is not implanted/explanted.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa the investigation could not be completed; no conclusion could be drawn, as no product was received.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing location: (b)(4), manufacturing date: 07.May.2010.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

An investigation summary was performed.Our investigation of the complained hammer have shown, that the present hammer is in a desolate condition.The blow surfaces show significant metal - chippings , also the shaft has dents on surface of possible hits.It is likely that violent hammer blows have led to a hardening of the material and this as a result of further hammer blows (over the years / article was manufactured may 2010) has favored the formation of chips.The instrument was analysed for conformance to print specifications, as well as the device history records were researched.No abnormal findings were identified.The device was used many times.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances, but excessive mechanical overload.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

Subject device has been received and is currently in the evaluation process.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: HAMMER 700 GRAMS
• Type of Device: HAMMER, SURGICAL
• Manufacturer (Section D): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-79 224; GM D-79224
• Manufacturer (Section G): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-79 224; GM D-79224
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4819587
• MDR Text Key: 15247664
• Report Number: 3003862213-2015-10024
• Device Sequence Number: 1
• Product Code: FZY
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 399.430
• Device Lot Number: 3431931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2010
• 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