MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH; WIRE, SURGICAL

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

Reportedly the issue occurred before there was patient involvement.The 510k: this report is for an unknown guide wire/unknown lot.Part and lot number are unknown; udi number is unknown.Device was not implanted/explanted.Complainant part is not expected to be returned for manufacturer.Review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported that while preparing the cannulated screw driver for surgery, it jammed with an unknown guide wire.This issue happened before use on patient.This report is for an unknown guide wire.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product investigation was completed.Upon visual inspection of the complained devices the unknown k-wire is completely damaged and jammed in the screwdriver.This complaint is confirmed.Device history record (dhr) could not be reviewed as article and lot number are not known.The relevant dimensions cannot be measured due to the damage incurred.The exact root cause for this occurrence could not be determined.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.

• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380
• MDR Report Key: 7074521
• MDR Text Key: 94362995
• Report Number: 8030965-2017-50226
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1