MAUDE Adverse Event Report: SYNTHES USA PEDICPROBE Ø2.8 L230

Catalog Number 388.538

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2016

Event Type  malfunction  

Manufacturer Narrative

This device was used for treatment, not diagnosis.(b)(4).Device is an instrument and is not implanted/explanted.(b)(6).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.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 (b)(6) reports an event as follows: it was reported that during an unknown surgery it was detected that the wooden handled instrument of a set appeared to have tiny wooden splinters shearing away while it was being used for hammering.The hospital checked the other two (2) sets and wear and tear were noted in all three (3) kits.After troubleshooting they were able to replace the screw without the surgery being prolonged.No information about patient condition received.Concomitant reported part: 1x screw (part and lot number unknown).This report is 4 of 4 for (b)(4).

• Brand Name: PEDICPROBE Ø2.8 L230
• Type of Device: PROBE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6095041
• MDR Text Key: 59853578
• Report Number: 2520274-2016-15345
• Device Sequence Number: 1
• Product Code: HXB
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388.538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2016
• 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
• Treatment: 1X SCREW (PART AND LOT NUMBER UNKNOWN)