MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH COMPRESSION SLEEVE FOR 3.0MM HEADLESS COMPRESSION SCREW; GUIDE

Catalog Number 03.226.000

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Injury (2348)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

A review of the device history record has been requested.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 a surgery with headless compression screws.During the surgery, the surgeon found that the instrument set delivered to the hospital contained the compression sleeve for 3.0 mm (03.226.000) instead of the compression sleeve for 2.4 mm (03.226.016).The surgeon had no choice but to insert 3.0 mm headless compression screws.He has concern for secondary fracture because the cortical bone became thinner due to the inserted screw size which is longer than planned one.There was no reported delay.The patient outcome was stable.This complaint involves two (2) devices.This is report 1 of 2 for (b)(4).

• Brand Name: COMPRESSION SLEEVE FOR 3.0MM HEADLESS COMPRESSION SCREW
• Type of Device: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester 19380 ; 6103142063
• MDR Report Key: 9907781
• MDR Text Key: 193647536
• Report Number: 8030965-2020-02465
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 07611819194267
• UDI-Public: (01)07611819194267
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03.226.000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2020
• 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
• Patient Outcome(s): Required Intervention