MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES PLATE,FIXATION,BONE

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: g5 ¿ 510k: this report is for an unknown plates/unknown lot. Part and lot numbers are unknown; udi number is unknown. 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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent the open reduction internal fixation (orif) surgery for ulnar distal end fractures by using the distal ulna plate. During the surgery, the surgeon had difficulty in engaging the sleeve with the plate. There was a surgical delay of less than thirty (30) minutes. The procedure was completed successfully. Concomitant devices reported: lcp drill sleeve 2 w/scal f/drill bit ø1 (part number 323. 034, lot 8117633, quantity 1), lcp drill sleeve 2 w/scal f/drill bit ø1 (part number 323. 034, lot 8476367, quantity 1). This report involves one (1) unknown plates. This is report 3 of 3 for (b)(4).

• Brand Name: UNK - PLATES
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10535959
• MDR Text Key: 207170257
• Report Number: 8030965-2020-06984
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown