MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SCREWHOLDER F/90° SCREWDRIVER WITHOUT INSERT; DRILL, BONE, POWERED

Catalog Number 03.505.010

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional procodes: dzj, hxx.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.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2018, the screw holder for 90 degrees screwdriver was noted to have difficulty sliding when used with the handle for 90 degrees screwdriver.It was also noted that the turning handle for 90 degrees screwdriver was also having a difficulty in sliding since the plating is peeling off.There was no patient involvement reported.It is unknown how the malfunction was discovered.This report is for a screw holder for 90° screwdriver without insert.This is report 1 of 3 for (b)(4).

• Brand Name: SCREWHOLDER F/90° SCREWDRIVER WITHOUT INSERT
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7974380
• MDR Text Key: 124010760
• Report Number: 8030965-2018-57390
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 07611819187504
• UDI-Public: (01)07611819187504
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082649
• 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: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.505.010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2018
• 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