MAUDE Adverse Event Report: SYNTHES GMBH HAMMER 500G; HAMMER,SURGICAL

Catalog Number 399.420

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device history lot.Part # 399.420, lot # l735219, manufacturing site: umkirch, release to warehouse date: (b)(6) 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 reports an event in (b)(6) as follows: it was reported on an unknown date that the handle of the hammer was broken off.It was unknown how and when it was occurred.There was no procedure or patient are involved.This complaint involves one (1) device.This report involves one (1) hammer 500g.This is report 1 of 1 for (b)(4).

• Brand Name: HAMMER 500G
• Type of Device: HAMMER,SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SYNTHES UMKIRCH (DE); im kirchenhürstle 4-6; umkirch bei freiburg 79224 ; GM 79224
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11212595
• MDR Text Key: 228170876
• Report Number: 8030965-2021-00530
• Device Sequence Number: 1
• Product Code: FZY
• UDI-Device Identifier: 07611819027824
• UDI-Public: (01)07611819027824
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 399.420
• Device Lot Number: L735219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2018
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1