MAUDE Adverse Event Report: SYNTHES GMBH TAP FOR DHS/DCS 12.5MM DIAMETER/220MM; TAP,BONE

Catalog Number 338.17

Device Problem Failure to Cut (2587)

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

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 that on an unknown post-operative date on (b)(6) 2021, it was identified that the tap for dhs/dcs is blunt and unusable.There was no patient involvement reported.This report is for one (1) tap for dhs/dcs 12.5mm diameter/220mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: TAP FOR DHS/DCS 12.5MM DIAMETER/220MM
• Type of Device: TAP,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12940855
• MDR Text Key: 286998838
• Report Number: 8030965-2021-09987
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 07611819022034
• UDI-Public: (01)07611819022034
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 338.17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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