MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DHS BLADE 12.5 L85 TAN; APPLIANCE,FIXATION,NAIL

Catalog Number 04.224.085S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4).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 open reduction internal fixation surgery for proximal femoral trochanteric fracture (reverse oblique fracture) with the dynamic hip screw (dhs) blade.After the incision was closed, and when the surgeon took x-rays, he found that he forgot to lock the blade.It was possible that the fixation of the blade will be weak because the blade wasn¿t locked.The hospital sterilized the instruments again for one (1) hours.The surgeon anesthetized the patient again about thirty (30) minutes and made incision and locked the blade.Patient outcome is reported as stable.The procedure was successfully completed.No further information is available.This report is for one (1) dhs blade ø12.5 l85 tan.This is report 1 of 1 for complaint (b)(4).

• Brand Name: DHS BLADE 12.5 L85 TAN
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10779247
• MDR Text Key: 217132382
• Report Number: 8030965-2020-08523
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819795495
• UDI-Public: (01)07611819795495
• 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: Physician
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.224.085S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR