MAUDE Adverse Event Report: SYNTHES GMBH CANNULATED CONNECTING SCREW; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 03.037.010

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: a device history record (dhr) review was conducted: visual inspection: the cannulated connecting screw (p/n: 03.037.010, lot #: 58p8814) was returned and received for analysis.Upon visual inspection, the threaded tip of the device is slightly peeled.No other issues were observed with the returned device.Dimensional inspection: a dimensional inspection cannot be performed due to post manufacturing damage.Complaint confirmed: yes, the complaint can be confirmed based on the available information.Investigation conclusion: the reported condition of the complaint device (cannulated connecting screw) is confirmed as the threads are peeled.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/ specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - part number: 03.037.010, lot number: 58p8814, manufacturing site: (b)(4), release to warehouse date: 16-july-2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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, the cannulated screw was bent and was hard to connect to nail.Concomitant device reported: unk - nails (part# unknown; lot# unknown; quality:1).This report is for one (1) cannulated connecting screw.This is report 1 of 1 for complaint (b)(4).

• Brand Name: CANNULATED CONNECTING SCREW
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13593168
• MDR Text Key: 286470041
• Report Number: 8030965-2022-01123
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070265
• UDI-Public: (01)10886982070265
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.010
• Device Catalogue Number: 03.037.010
• Device Lot Number: 58P8814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2020
• 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
• Treatment: UNK - NAILS