MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18MM; NAIL,FIXATION,BONE

Catalog Number 212.105

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Manufacturer Narrative

Additional procode: ktt.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 an unknown date,(18) locking screws were found to have incorrect quantities in the packaging.The packing is meant to contain six units but the affected packing only contained three or four units.The issue was found before the procedure.The implants were intended for a bilateral hip procedure.Due to the shortage of screws, the surgeon decided to operate on the patient's right side only.There is no further information available.This report is for (1) 3.5mm locking screw slf-tpng w/stardrive(tm) recess 18mm.This is report 16 of 18 for (b)(4).

• Brand Name: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18MM
• Type of Device: NAIL,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: 12046073
• MDR Text Key: 262555089
• Report Number: 8030965-2021-05195
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 07611819125766
• UDI-Public: (01)07611819125766
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K072095
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 212.105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2021
• 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