MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 50MM F/IM NAILS-STER; SCREW, FIXATION, BONE

Catalog Number 04.005.440S

Device Problems Device-Device Incompatibility (2919); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional device product code: hsb.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part: 04.005.440s, lot: 9538229, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: 25.June 2015, expiry date: 01.June 2025.Device was first manufactured unsterile under the lot 9525522 in mezzovico and sterilized afterwards.As this complaint is neither packaging nor sterilization related only the manufacturing documents of the unsterile device 04.005.440 with lot 9525522 were reviewed: a manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 proximal humeral fractures by using the multiloc humeral nails system.During the surgery,at the time of final fixation at the distal end, the surgeon inserted the locking screw.When he tried to pull out the driver, the locking screw was also pulled out together.The surgery was successfully completed without any delay.The surgeon comments that due to the bad bone quality the locking screw was probably pulled out.Patient outcome is reported as stable.No further information is available.Concomitant device reported: screwdriver (part# unknown, lot# unknown, quantity 1); nail (part# unknown, lot# unknown, quantity 1).This report is for one (1) 4.0mm ti locking screw w/t25 stardrive 50mm f/im nails-ster.This is report 1 of 1 for (b)(4).

• Brand Name: 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 50MM F/IM NAILS-STER
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10472399
• MDR Text Key: 204960201
• Report Number: 8030965-2020-06493
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819789616
• UDI-Public: (01)07611819789616
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103002
• 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: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.005.440S
• Device Lot Number: 9538229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - NAILS: MULTILOC HUMERAL; UNK - SCREWDRIVERS
• Patient Age: 77 YR
• Patient Weight: 60