MAUDE Adverse Event Report: SYNTHES SELZACH 2.0MM IMF SCREW SELF-DRILLING 12MM¿STERILE; SCREW FIXATION INTRAOSSEOUS

Catalog Number 201.932S

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/03/2016

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.(b)(4).Potential lot numbers of 9513055, 9726092, 9569547 or 9220229 were provided.It is unknown which is the complained screw.Device broke during insertion; device not considered implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).A review of the device history records for all the potential lot numbers was completed: sterile part 201.932s, lot 9513055: manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: june 09, 2015.Expiry date: may 01, 2025.Non-sterile part 201.932, lot 9490162: manufacturing location: (b)(4).Manufacturing date: may 18, 2015.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterile part 201.932s , lot 9726092: manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: november 12, 2015.Expiry date: november 01, 2025.Non-sterile part 201.932 , lot 9697315: manufacturing location: (b)(4).Manufacturing date: october 22, 2015.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterile part 201.932s , lot 9569547: manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: july 17, 2015.Expiry date: july 01, 2025.Non-sterile part 201.932 , lot 9533902: manufacturing location: (b)(4).Manufacturing date: june 23, 2015.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterile part 201.932s , lot 9220229: manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: october 28, 2014.Expiry date: october 01, 2024.Non-sterile part 201.932 , lot 9139562: manufacturing location: (b)(4).Manufacturing date: september 10, 2014.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in the (b)(6) as follows: it was reported that a screw head broke off during insertion.The screw tip was left in the patient.Surgery was prolonged about five (5) minutes.No information about patient condition received.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).The subject device has been received and is currently in the evaluation process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product investigation summary: a screw head was received with the threaded part broken about 5mm below the head.The forefront of the thread was not sent back for evaluation as it was reportedly left in the patient.The relevant dimensions of the intramedullary fixation screw were checked and found to be in compliance with the technical drawings and specifications.The core diameter at the fracture face was found to be 1.36mm, which is within the specification of 1.35mm +/-0.05 according to the relevant drawing.The examination of the raw-material testing certificate and the manufacturing papers of all four potential lot numbers showed no deviations regarding dimensions, material analysis, strength, and/or structural stability.The values were in compliance with specifications and international standards.The fracture face is homogenous, which indicates material conformity and has the typical view of a forced rupture.No manufacturing related issues could be detected.Based on the provided information, the exact cause of this occurrence could not be determined.The appearance of the fracture face indicates that a mechanical overload, for example by dense bone, caused the breakage of this screw.In this relation, it is important to mention that the surgical technique cautions that, in dense cortical bone, it may be necessary to predrill with a b 1.5 mm drill bit.No product related issues could be detected.Device 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.

• Brand Name: 2.0MM IMF SCREW SELF-DRILLING 12MM¿STERILE
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5663894
• MDR Text Key: 45419826
• Report Number: 3000270450-2016-10122
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK010527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201.932S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/03/2016
• Initial Date FDA Received: 05/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/08/2016; 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention