MAUDE Adverse Event Report: SYNTHES GMBH SPEED SHIFT 15X20X20X08MM IMPLANT; STAPLE, FIXATION, BONE

Model Number SE-1520-08

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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 the (b)(6) reports an event as follows: it was reported that on an unknown date, the sales representative received sample product where it appeared that the cci was compressed prior to the pack being opened.When the pack was opened, the insertion handle fell apart.This report is for a speed shift 15x20x20x08mm implant.This is report 1 of 1 for (b)(4).

• Brand Name: SPEED SHIFT 15X20X20X08MM IMPLANT
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): BIO MEDICAL ENTERPRISES INC; 14785 omicron dr # 205; san antonio TX 78245
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12313666
• MDR Text Key: 266239673
• Report Number: 8030965-2021-06601
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633020432
• UDI-Public: (01)00810633020432
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142292
• 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: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SE-1520-08
• Device Catalogue Number: SE-1520-08
• Device Lot Number: BMESE160303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2021
• 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