MAUDE Adverse Event Report: SYNTHES PRODUKTIONS GMBH MF-CORTSCR Ø2 SELF-TAP L6 TI; SCREW, FIXATION, BONE

Catalog Number 401.106

Device Problems Component Missing (2306); Incomplete or Missing Packaging (2312)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device returned.Occupation: synthes rep.A review of the device history record: device history lot: part: 401.106, lot: l250632, manufacturing site: (b)(4).Release to warehouse date: 26.Dec.2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary we have forwarded the complaint to the responsible manufacturing site for investigation with the following results: summary: the depuy synthes bag was received empty and closed.The package matches with the received label.The received depuy synthes bag is free of dirt or damages and it is sealed.A manufacturing record evaluation was performed for the affected lot l250632, where no non-conformances, abnormalities nor deviations were identified which could lead to the complaint failure.In addition, the drawing of the article 401.106 (se_608618 rev.A) valid at the time of manufacturing, was reviewed and no relevant design changes where identified.During the manufacturing process, the lot was inspected 100% through the work instruction se_517653 rev.Ae in the step 0047 ¿inspection of documentation, product and label¿ however, the empty bag in question was not detected in the process packaging 0040, equipment number: 10007718.In this manual packaging process, the operator is in responsible of supplying the machine with the screws.After finishing packaging, the operator checks the packed parts to make sure that all the screws are packed in their respective bags.Based on the investigation results, this complaint is rated as confirm as well as valid since the received depuy synthes bag is welded and empty as claimed by the customer.Besides, this issue is currently addressed through the relevant actions that have been taken to address the issue.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: 401.106 x 1 (lot l250632) mf cortex screw ø 2.0 mm, self-tapping, length 6 mm, pure titanium, was found missing in a sealed package during pre-operation check.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: MF-CORTSCR Ø2 SELF-TAP L6 TI
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES PRODUKTIONS GMBH; muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; muracherstrasse 3; bettlach 2544 ; SZ 2544 ; 6103142063
• MDR Report Key: 9050320
• MDR Text Key: 200275876
• Report Number: 9612488-2019-50004
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819028678
• UDI-Public: (01)07611819028678
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 401.106
• Device Lot Number: L250632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1