MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DHS®/DCS® LAG SCREW 12.7MM THREAD/85MM; APPLIANCE, FIXATION, BONE

Catalog Number 280.850

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).Without a lot number the device history records review or the investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, and on an unknown procedure, a dynamic hip and condylar screw system (dhs/dcs) had not been used by the surgeon because the dhs/dcs lag screw did not fit in the unknown screwdriver.It was unknown if there were any surgical delay and/or adverse event to the patient.This report is for (1) dhs®/dcs® lag screw 12.7mm thread/85mm.This complaint involves two (2) device.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional information provided.Part: 280.850; lot: l215459; manufacturing site: balsthal; release to warehouse date: november 23, 2016.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Investigation selection.Investigation site: cq zuchwil.Selected flow(s): 2.Device interaction/functional and 3.Damaged: visual | examples: deformed/bent/cracked visual inspection: upon visual inspection of the complaint device, it can be seen that the distal end of the device is deformed from use, thus confirming the complaint description.Furthermore, the part has all-over scratches and dents visible.Functional test: a function test is based on the already mentioned deformation, scratches and dents are not possible anymore.Document/specification review: drawings and revisions are in accordance to device history record (dhr) of production lot l215459.All relevant features are defined on the used drawing revisions of dhr of production lot l215459.A dhr review was performed for the affected lot; (b)(4) parts were delivered to the warehouse; no abnormalities or deviations were detected which could lead to the complaint failure.The article was manufactured in november 2016.No nonconformance reports (ncrs) were marked in the dhr during production.Moreover, a review of our complaints data base shows that there are no other complaints for this issue from this article and lot number.Dimensional inspection: during investigation, the diameter was measured with a micrometer: specification: 7.90 0/-0.05mm result: 7.99mm; failed, based on the deformation summary: there is no particular information on what's happened to this article by the customer.Unfortunately, we are not able to determine the exact reason for this occurrence.We have to assume that excessive force led to this damage or/and that during the operation an application error may have taken place.To prevent such problems, it is necessary for worn or damaged instruments to be replaced and/or to be operated according to the surgical technique.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: DHS®/DCS® LAG SCREW 12.7MM THREAD/85MM
• Type of Device: APPLIANCE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8005086
• MDR Text Key: 124998416
• Report Number: 8030965-2018-57605
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819012714
• UDI-Public: (01)07611819012714
• Combination Product (y/n): N
• PMA/PMN Number: K791619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.850
• Device Lot Number: L215459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Date Manufacturer Received: 11/21/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention