MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TURNING HANDLE F/90° SCRWDRVR; DRILL, BONE, POWERED

Catalog Number	03.505.005
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional pro codes: 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 or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2018, the screwholder 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 turning handle for 90° screwdriver.This is report 3 of 3 for (b)(4).

• Brand Name: TURNING HANDLE F/90° SCRWDRVR
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7974465
• Report Number: 8030965-2018-57393
• Device Sequence Number: 16457616
• Product Code: DZI
• UDI-Device Identifier: 07611819187498
• UDI-Public: (01)07611819187498
• Combination Product (Y/N): N
• PMA/510(K) Number: K082649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.505.005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1