MAUDE Adverse Event Report: SYNTHES GMBH SCREWDRIVER STARDRIVE T15/ SELF-RETAINING/272MM; GAUGE,DEPTH

Catalog Number 03.113.021

Device Problem Device-Device Incompatibility (2919)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j sales representative.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot part number: 03.113.021, lot number: 91p5068, manufacturing site: (b)(4), release to warehouse date: march 24, 2021.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 on june 21, 2021, the guiding block and the locking attachment plate got stuck and were not come off during assembly for demonstration.Also, the guiding block came off eventually.As well as the connecting screw also came off at the same time.The tip of the screwdriver which was used to lock the upper part of the connecting screw had been chipped off.The screwdriver was unable to grasp the upper part of the connecting screw.These devices and implants were prepared for demonstration in study meeting.These events dont include any patients.No further information is available.This complaint involves six (6) devices.This report is for (1) screwdriver stardrive t15/ self-retaining/272mm.This report is 4 of 6 for (b)(4).

• Brand Name: SCREWDRIVER STARDRIVE T15/ SELF-RETAINING/272MM
• Type of Device: GAUGE,DEPTH
• 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: 12193514
• MDR Text Key: 262665729
• Report Number: 8030965-2021-05899
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819334427
• UDI-Public: (01)07611819334427
• 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: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.113.021
• Device Lot Number: 91P5068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1