MAUDE Adverse Event Report: SYNTHES BETTLACH LOCKSCR Ø5 SELF-TAP L80 TAN; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number 413.380

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

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.(b)(6).Date of device breakage is not known.Date of implant is not known.It is not known if devices were explanted.Date returned to manufacturer.Concomitant device therapy date is not known.(b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Dhr has been requested.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 (b)(4) reports an event in (b)(6) as follows:it was reported that postoperatively multiple screw heads broke which were used in combination with a locking compression (lcp) distal femur plate.Patient was implanted with a locking compression plate (lcp) distal femur plate and unknown quantity of screws on unknown date.On unknown date it was determined that the heads of multiple screws are broken.Quantity of broken screws is not known.It is also not known if patient will be returned to surgery for removal of the broken devices.This report is for unknown quantity of unknown screws.Concomitant devices reported: 422.253 lot number 8532746 lcp-plate (part / lot: unknown, quantity: 1) this is report 2 of 3 for (b)(4).

Manufacturer Narrative

Updated information provided.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

Update: 26 july 2017, it was reported that postoperatively multiple screw heads broke which were used in combination with a locking compression (lcp) distal femur plate.A total of three (3) screws broke post-operatively.

Manufacturer Narrative

Device history records review was conducted.The report indicates that the: 413.380/ 8212474.Manufacturing location: (b)(4).Manufacturing date: 21.Dec.2012.No ncrs 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.A product evaluation was performed.The investigation of the complaint articles indicates that the: dimension.The relevant measurable dimensions of the two locking screws (413.375 / 413.380) can not be determined, because the shafts are missing and the screws head stucks in the lcp-df plate.The hexagon recess of these two locking screws are strongly damaged.Material: the examination of the raw-material testing certificate and the manufacturing papers showed no deviations regarding, dimensions, material analysis, strength and structural stability.The values were in compliance with ao/asif specification and with the international standard iso 5832-11 for tan (wrought titanium 6-aluminium 7-niobium alloy).The fracture face is homogenous, which indicates material conformity.Conclusion: no product fault could be detected.The article 413.375 / lot 9457058 was manufactured with a lot size of 240 pieces in april 2015 and we are not aware of any other complaint for this article- and lot number.The article 413.380 / lot 8212474 was manufactured with a lot size of 239 pieces in december 2012 and we are not aware of any other complaint for this article- and lot number.The evaluation of the two locking screws shown that the screw heads stuck in the lcp-df-plate.The shafts are missing and for further investigation not available.According statement of clinic, the screws were discarded by the hospital.Further investigation of the screw heads are shown that the hexagon recess are strongly damaged.The reason for the breakage and deformation we can not determined.We can only assume that this can be traced during insertion or removal or there was a complication during operation or the healing process that caused this problem.Complaint is disposed as confirmed due to evidence that screws are broken, but it's considered not valid for manufacturing standpoint because there is no evidence of issues manufacturing related.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.

Manufacturer Narrative

Remove verbiage: it is also not known if patient will be returned to surgery for removal of the broken devices.Remove verbiage: date of implant is not known / it is not known if devices were explanted 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.

• Brand Name: LOCKSCR Ø5 SELF-TAP L80 TAN
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach PA CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6742757
• MDR Text Key: 80987237
• Report Number: 2520274-2017-11982
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819240674
• UDI-Public: (01)07611819240674(10)8212474
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023941
• 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,Followup
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 413.380
• Device Lot Number: 8212474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2017
• 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
• Patient Age: 64 YR
• Patient Weight: 93