MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BENDING IRON FOR 1.25MM, 1.6MM & 2.0MM KIRSCHNER WIRES; INSTR,BENDING OR CONTOURING

Catalog Number 392.000

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Occupation: initial reporter is synthes sales representative device history lot, part: 392.000, lot: 2028347, manufacturing site: (b)(4), release to warehouse date: 02.May.2002.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this 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.

Event Description

Device report from synthes reports an event in (b)(4) as follows: it was reported that on (b)(6) 2019, they were unable to remove a wire from a bending iron for kirshner wire.It is unknown when the issue was discovered.The procedure outcome is unknown and there was no patient involvement.This report is for one (1) bending iron for 1.25mm, 1.6mm & 2.0mm kirschner wires.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device history lot part: 392.000 lot: 2028347 manufacturing site: bettlach release to warehouse date: 02.May.2002 the device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this 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: BENDING IRON FOR 1.25MM, 1.6MM & 2.0MM KIRSCHNER WIRES
• Type of Device: INSTR,BENDING OR CONTOURING
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8343038
• MDR Text Key: 136278301
• Report Number: 8030965-2019-61051
• Device Sequence Number: 1
• Product Code: HXP
• UDI-Device Identifier: 07611819024847
• UDI-Public: (01)07611819024847
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 392.000
• Device Lot Number: 2028347
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1