MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH WIRE CUTTER 220MM; CUTTER, WIRE

Catalog Number 391.93

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales representative the investigation could not be completed; no conclusion could be drawn, as no product was received.Device history lot part number: 391.93, lot number: 2100, manufacturing site: unknown, release to warehouse date: unknown.Part/lot combination are unknown at synthes (b)(4), no dhr review possible.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 date, the wire cutter was broken.No patient involvement reported.No further information is available.This report is for one (1) wire cutter 220mm.This is report 1 of 1 for (b)(4).

• Brand Name: WIRE CUTTER 220MM
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10254334
• MDR Text Key: 198355549
• Report Number: 8030965-2020-04766
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 07611819024779
• UDI-Public: (01)07611819024779
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391.93
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2020
• 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