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

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unk - plates: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 via email from the healthcare practitioner (hcp) that, on march 16,2021 he had a problem with the 3 drill sleeve that could hardly be turned into the angular stable threaded holes of the 130° hip plate 5.0, neither at the proximal end for the femoral neck screws nor distally for the shaft screws.This was particularly problematic proximally after placement of the femoral neck wires.It could be a thread mismatch here or the threads of the drill sleeves are no longer good.In addition, the drill sleeves are difficult to handle and screw in with wet fingers (if you have found the correct direction), also the key grips poorly.Procedure was completed successfully.This report is for one (1) unk - plates.This is report 4 of 7 for complaint (b)(4).

• Brand Name: UNK - PLATES
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11667330
• MDR Text Key: 245517365
• Report Number: 8030965-2021-02911
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1